Oggi in Oncologia
  

Oncogenic alterations in RET have been identified in multiple tumour types, including 1-2% of non-small-cell lung cancers (NSCLCs). We aimed to assess the safety, tolerability, and antitumour activity of pralsetinib, a highly potent, oral, selective RET inhibitor, in patients with RET fusion-positive NSCLC. ARROW is a multi-cohort, open-label, phase 1/2 study done at 71 sites (community … (leggi tutto)

I riarrangiamenti del gene Rearranged during Transfection (RET) sono implicati nella patogenesi di diversi tumori, fra cui il tumore polmonare non a piccole cellule (Non-Small Cell Lung Cancer, NSCLC) e il carcinoma tiroideo. Il riarrangiamento cromosomico di RET dà origine a geni di fusione chimerici che sono presenti in circa 1-2% dei NSCLC e che rappresentano un nuovo target terapeutico. pralsetinib, conosciuto anche come BLU-667, è un inibitore tirosin chinasico orale altamente attivo contro le fusioni del gene RET, inclusa la mutazione gatekeeper V804 tradizionalmente associata a un alto tasso di resistenza.
Sulla rivista Lancet Oncology è stata recentemente pubblicata da Gainor et al. l’analisi ad interim del trial di fase 1\2 ARROW, che ha evidenziato per pralsetinib un alto tasso di risposta in pazienti con tumore polmonare non a piccole cellule RET+. Lo studio clinico multicentrico di fase 1\2 ARROW ha arruolato 233 pazienti da marzo 2017 a maggio 2020, includendo 87 pazienti trattati precedentemente con chemioterapia a base di platino e 27 pazienti non eleggibili alla terapia con platino e non pre-trattati. Pralsetinib è stato somministrato ad una dose di 400 mg/die. Gli obiettivi primari scelti sono stati l’Overall Response Rate (ORR) e la safety.
Nella coorte dei pazienti pretrattati, l’ORR era del 61% (IC 95%: 50 – 71) con un tasso di risposte complete del 6% ed una Duration of Response (DOR) mediana di 9 mesi. Nella coorte di pazienti naïve al trattamento l’ORR è stato del 70% (19/27 pazienti; IC 95%: 50 – 86), con risposte complete evidenziabili in 3 pazienti. Le risposte sono state confermate come indipendenti dal tipo di fusione di RET. Inoltre, pralsetinib ha mostrato un’interessante efficacia intracranica in 5\9 pazienti (56%; IC 95%: 21 – 86), di cui 3 risposte complete.
Per quanto riguarda le tossicità, circa il 48% dei pazienti ha riportato una reazione avversa di grado ≥ 3, tra cui le più frequenti sono state neutropenia (18%), ipertensione (11%) e anemia (10%). Reazioni avverse di grado severo sono state polmoniti, anemia e neutropenia, confermate in circa il 24% dei pazienti. Non sono state riportati decessi correlati al trattamento.
Sulla base di questi dati, la Food and Drug Administration (FDA) ha concesso il fast-approval di pralsetinib per il trattamento di pazienti con NSCLC avanzato in presenza di fusioni del gene RET.
Pertanto, in questo scenario è auspicabile come una profilazione genomica estesa mediante sequenziamento genico di nuova generazione includa il testing di tali alterazioni geniche nei pazienti affetti da NSCLC avanzato, diventando parte integrante dell’inquadramento biomolecolare della neoplasia al fine di ottimizzare la strategia terapeutica di trattamento.

MRI-Targeted or Standard Biopsy in Prostate Cancer Screening

High rates of overdiagnosis are a critical barrier to organized prostate cancer screening. Magnetic resonance imaging (MRI) with targeted biopsy has shown the potential to address this challenge, but the implications of its use in the context of organized prostate cancer screening are unknown. We conducted a population-based noninferiority trial of prostate cancer screening in … (leggi tutto)

Il programma di screening del carcinoma prostatico che includa l’analisi del PSA e la biopsia prostatica transrettale eco-guidata riduce la mortalità per cancro prostatico, seppur con un alto tasso di sovradiagnosi, overtreatment, e conseguentemente con un elevato numero di biopsie non utili ai pazienti. Negli ultimi anni, una grande innovazione in tale ambito è stata la biopsia prostatica RMN-guidata, che risulta essere più precisa, permettendo di ridurre il numero di prelievi bioptici e di complicanze legate alla procedura, aumentando il tasso di diagnosi di tumori prostatici clinicamente rilevanti.
Attualmente questa metodica è già entrata nella pratica clinica della diagnosi del carcinoma prostatico, tuttavia l’uso è ancora limitato e non ci sono dati sul suo utilizzo nel contesto di screening nazionali.
Lo studio di fase 3 STHLM3-MRI, recentemente pubblicato sul New England Journal of Medicine da Eklund et al. e i cui dati sono stati presentati al 36° congresso annuale dell’European Association of Urology, è un trial prospettico randomizzato con disegno di non-inferiorità, finalizzato a valutare il contributo della RMN nello screening del carcinoma prostatico per uomini nella fascia d’età 50-74 anni. In particolar modo, gli autori hanno valutato l’efficacia della biopsia prostatica RMN-guidata (coorte sperimentale) rispetto alla biopsia prostatica standard. I pazienti con un livello di PSA ≥ 3 ng/ml sono stati randomizzati a sottoporsi alla biopsia standard (Gruppo A) o a sottoporsi a RMN, seguita da biopsia standard e biopsia RMN-guidata, laddove il risultato della RMN indicasse un sospetto di carcinoma prostatico (Gruppo B). Outcome primario dello studio era la proporzione di soggetti con diagnosi di carcinoma prostatico Gleason Score ≥ 7 nella popolazione ITT, mentre endpoint secondario dello studio era la percentuale di carcinoma prostatico individuati con Gleason Score 6. Sono stati arruolati circa 12.750 soggetti tra febbraio 2018 e marzo 2020, di cui 1.532 con PSA elevato sono stati randomizzati nei due gruppi, rispettivamente 603 gruppo A con biopsia standard e 929 gruppo B con biopsia RMN-guidata e standard. Nell’ITT population, 192 uomini del gruppo B hanno ricevuto una diagnosi di carcinoma prostatico clinicamente rilevante, mentre 106 uomini del gruppo A con una differenza del 3% (statisticamente significativo per la non-inferiorità). Inoltre, la percentuale di carcinomi con un Gleason Score di 6 è stata più bassa nel gruppo sperimentale, rispetto al gruppo con la biopsia standard (41 vs 73 soggetti). Sulla base di questi dati, tale studio ha dimostrato, in uno scenario legato allo screening del tumore prostatico, che uomini sopra i 50 anni con un elevato valore di PSA e una RMN negativa potrebbero evitare la biopsia prostatica.

Molecular determinants of response to PD-L1 blockade across tumor types

Immune checkpoint inhibitors targeting the PD-1/PD-L1 axis lead to durable clinical responses in subsets of cancer patients across multiple indications, including non-small cell lung cancer (NSCLC), urothelial carcinoma (UC) and renal cell carcinoma (RCC). Herein, we complement PD-L1 immunohistochemistry (IHC) and tumor mutation burden (TMB) with RNA-seq in 366 patients to identify … (leggi tutto)

Su Nature Communications sono stati recentemente pubblicati i risultati di uno studio volto a ricercare i determinanti molecolari della risposta agli inibitori dei checkpoint immunitari (ICI) in vari istotipi tumorali. Nonostante, nel complesso, questi farmaci (anti-CTLA-4, anti-PD-1 e anti-PD-L1) abbiano mostrato risultati clinicamente importanti, soltanto un sottogruppo di pazienti mostra delle risposte a lungo termine, soprattutto nel caso in cui vengano somministrati come monoterapia. L’identificazione di biomarcatori predittivi di risposta o resistenza al trattamento sarebbe, pertanto, utile a discriminare i pazienti responder dai non-responder. Numerosi studi hanno utilizzato l’espressione di PD-L1 valutata su tessuto tumorale in immunoistochimica e il Tumor Mutational Burden (TMB) come possibili biomarcatori. Tuttavia, i risultati sono stati molto eterogenei, supportando la necessità di ottenere dei biomarcatori dotati di una maggiore accuratezza.
In questo studio, gli autori integrano l’espressione di PD-L1 in immunoistochimica e TMB con il profilo trascrizionale della neoplasia, studiato attraverso RNA-seq, allo scopo di identificare i profili molecolari utili nel predire la risposta. Le analisi sono state effettuate su 366 campioni tumorali, provenienti da 3 studi clinici che hanno utilizzato l’anticorpo monoclonale anti-PD-L1 atezolizumab in pazienti con malattia localmente avanzata o metastatica: 208 pazienti con carcinoma uroteliale (UC) (Studio IMvigor210), 81 pazienti con carcinoma polmonare non a piccole cellule (NSCLC) (Studio POPLAR), e 77 pazienti con carcinoma renale (RCC) (Studio IMmotion150).
I risultati suggeriscono innanzitutto una eterogeneità molecolare tra i differenti tumori, uroteliali, polmonari e renali. A livello di pathway, l’eterogeneità è evidente in particolare nell’ambito dei tumori PD-L1+. Le neoplasie uroteliali e polmonari sembrano essere maggiormente allineate, con i geni implicati nel controllo del ciclo cellulare e del danno al DNA, associati alla risposta nei tumori PD-L1-. A livello genico, CDKN2A, gene che codifica per p16, inibitore endogeno delle chinasi ciclina-dipendenti CDK4 e CDK6, risulta essere associato alla risposta, mettendo in evidenza come anche vie “non immuni” possano influenzare la risposta al trattamento immunoterapico.
Pertanto, nonostante l’utilizzo di sofisticate tecniche di machine learning, non è stata identificata una firma trascrizionale, comune alle 3 neoplasie in studio, che possa definirsi altamente predittiva della risposta al trattamento. Diversi fattori sembrano influenzare la risposta agli ICI, e questo studio ci mostra come in parte siano dipendenti dal tipo di tumore. Alla luce di tali considerazioni, per lo sviluppo di biomarcatori predittivi di risposta o resistenza all’immunoterapia, in futuro sarà fondamentale considerare i contesti molecolari specifici delle singole neoplasie in cui tali farmaci vengono somministrati.

 


In Europa

 

Tafasitamab Plus Lenalidomide Approved in Europe for Relapsed/Refractory DLBCL

Aug 27, 2021 – The European Commission has granted a conditional marketing authorization to tafasitamab plus lenalidomide followed by single-agent tafasitamab for use in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant (ASCT). The regulatory decision follows a positive opinion issued in June … (leggi tutto)

Amid Ethics Allegations, Sesen Pulls Bladder Cancer Drug Application from Europe

Aug 26, 2021 – Less than 10 days after the U.S. Food and Drug Administration (FDA) slammed Sesen Bio’s bladder cancer drug with a Complete Response Letter, the company has withdrawn its Marketing Application Authorization from the European Union. In a filing with the U.S. Securities and Exchange Commission, Sesen Bio said its decision to pull the MAA was based on the … (leggi tutto)

FDA and EMA Accept Tebentafusp Applications for Metastatic Uveal Melanoma

Aug 24, 2021 – The FDA and the European Medicines Agency (EMA) have accepted applications seeking the approval of tebentafusp (IMCgp100) for use in the treatment of adult patients with HLA-A*02:01–positive metastatic uveal melanoma. In the United States, the regulatory agency has granted priority review to the biologics license application for the agent. The FDA is expected … (leggi tutto)

Nivolumab in combination with chemotherapy in the treatment of oesophagus and stomach cancer

Aug 24, 2021 – EAMS scientific opinion issued to Bristol Myers Squibb for nivolumab in combination with chemotherapy for the treatment of cancer of the stomach or oesophagus (gullet) that has spread beyond the stomach or oesophagus. The scientific opinion includes: a public assessment report (PAR); a treatment protocol: for healthcare professionals, for patients, on the … (leggi tutto)

Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna

Aug 24, 2021 – EMA’s human medicines committee (CHMP) has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. CHMP has approved an additional manufacturing site for the production of the COVID-19 vaccine developed by BioNTech and Pfizer. The site, located in Saint Rémy sur Avre, France, is operated by … (leggi tutto)

First monoclonal antibody treatment for COVID-19 approved for use in the UK

Aug 20, 2021 – Following on from a thorough review of the evidence carried out by the MHRA, and recommendation by the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body, the MHRA has approved casirivimab and imdevimab as the first monoclonal antibody combination product indicated for use in the prevention and … (leggi tutto)

Idecabtagene Vicleucel Approved in Europe for Relapsed/Refractory Multiple Myeloma

Aug 19, 2021 – The European Commission (EC) has granted a conditional marketing authorization for idecabtagene vicleucel (ide-cel) for use in adult patients with relapsed/refractory multiple myeloma who have previously received at least 3 therapies, including an immunomodulatory drug (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody and progressed on … (leggi tutto)

Moderna COVID-19 vaccine approved by MHRA in 12-17 year olds

Aug 17, 2021 – An extension to the current UK approval of the COVID-19 Vaccine Moderna that allows its use in 12- to 17-year-olds has today been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA). This Conditional Marketing Authorisation (CMA) extension granted by the MHRA is valid in Great Britain only and was approved via the European Commission … (leggi tutto)

EMA Validates Applications for Nivolumab/Ipilimumab, Nivolumab/Chemo in Frontline ESCC

Aug 17, 2021 – The European Medicines Agency has validated its Type II Variation Marketing Authorization Applications for nivolumab plus ipilimumab  and nivolumab plus fluoropyrimidine- and platinum-containing chemotherapy as frontline options for adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) … (leggi tutto)

EMA starts evaluating use of Tocilizumab in hospitalised adults with severe COVID-19

Aug 16, 2021 – EMA has started evaluating the anti-inflammatory medicine tocilizumab to extend its use to include treatment of hospitalised adult patients with severe COVID-19 who are already receiving treatment with corticosteroids and require extra oxygen or mechanical ventilation (breathing assisted by a machine). Tocilizumab is considered a potential treatment for COVID-19 … (leggi tutto)

Artificial intelligence in medicine regulation

Aug 16, 2021 – The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published today. AI includes various technologies (such as statistical models, diverse algorithms and self-modifying systems) that are … (leggi tutto)

NICE Recommends Abemaciclib for HR+/HER2– Advanced Breast Cancer

Aug 12, 2021 – The United Kingdom’s National Institute for Health and Care Excellence (NICE) has issued draft guidance supporting the use of abemaciclib in the treatment of adult patients with metastatic hormone receptor (HR)–positive/HER2-negative breast cancer. The announcement reverses a February decision denying approval for routine use of the agent because the CDK4/6 … (leggi tutto)

Northern Ireland: EU continues to look for Solutions – with interesting Forms of Documents

Aug 11, 2021 – Have you ever heard of a “non-paper”? That is the name given by the EU Commission to a new document that describes proposed solutions for the practical handling of problems within the framework of the Northern Ireland Protocol. The exact title is “Non-Paper: Medicines and the Implementation of the Protocol on Ireland and Northern Ireland”; it was published on … (leggi tutto)

New Work Sharing Initiative from the Access Consortium for assessment of Biosimilar applications

Aug 11, 2021 – The Access Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia’s Therapeutic Goods Administration (TGA), Health Canada (HC), Singapore’s Health Sciences Authority (HSA), the Swiss Agency for Therapeutic Products (Swissmedic) of Switzerland and the Medicines and Healthcare products Regulatory … (leggi tutto)

Interoperability of track and trace systems: key to public health protection

Aug 6, 2021 – EMA has endorsed recommendations developed by the International Coalition of Medicines Regulatory Authorities (ICMRA) to facilitate the use of track and trace systems at the global level. The paper published today identifies common technical denominators that allow different systems to exchange and use the available information on medicines and their supply … (leggi tutto)

ECDC and EMA update on COVID-19

Aug 4, 2021 – Full vaccination is key to protecting against serious COVID-19, including disease caused by the Delta variant. With the increasing circulation of the Delta variant of SARS-CoV-2 in EU/EEA countries, the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) strongly encourage those who are eligible for vaccination … (leggi tutto)

Clinical Trials: Application of the CTR confirmed as of 31 January 2022

Aug 4, 2021 – It is now officially confirmed: On 31 January 2022, the Clinical Trials Regulation 536/2014 (CTR) will become applicable. This means some significant changes for clinical trials in Europe with regard to the processes and procedures for authorizing, conducting and terminating clinical trials. What GMP / GCP changes are coming in connection with the CTR? On 31 July 2021, the EU … (leggi tutto)

Recipients of the 2021 ESMO Awards revealed

Aug 3, 2021 – ESMO has announced today the winners of the 2021 Society Awards. This year’s recipients of the four prestigious distinctions are leaders in their respective fields who have also helped many of their fellow oncologists to advance in their professional careers. The award lectures will be delivered during the ESMO Congress 2021. The 2021 awardees are: ESMO … (leggi tutto)

Medicines that you cannot export from the UK or hoard

Aug 3, 2021 – This document lists the medicines that cannot be exported from the UK or hoarded. The list is updated regularly. The government has produced guidance on export and hoarding of restricted medicines. In October 2019 a letter to holders of a wholesale dealer licence was sent out about the restrictions on parallel exports. From 1 January 2021 you may no longer … (leggi tutto)

Six-month countdown to go-live for the Clinical Trials Information System (CTIS)

Aug 2, 2021 – The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and hence the go-live date for the Clinical Trials Information System (CTIS) will be on 31 January 2022. As set out in the Clinical Trials Regulation, the entry into application of that Regulation is set by the publication of a notice in the Official Journal of the European Union … (leggi tutto)

Adjuvant Nivolumab Approved in Europe for Select Esophageal or GEJ Cancers

Jul 30, 2021 – The European Commission has approved nivolumab for use as an adjuvant treatment in adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease after neoadjuvant chemoradiation. The approval was supported by data from the phase 3 CheckMate-577 trial (NCT02743494), which demonstrated that adjuvant … (leggi tutto)

Increased manufacturing capacity and supply for Moderna’s COVID-19 vaccine

Jul 30, 2021 – EMA’s human medicines committee (CHMP) has approved a scale-up of the active substance production process at Moderna’s COVID-19 vaccine manufacturing sites in the United States (US). This recommendation is expected to have significant impact on the supply of the COVID-19 vaccine developed by Moderna in the European Union. It is estimated that … (leggi tutto)

EMA Recommends Granting a Marketing Authorisation for the Hybrid Medicine Imatinib

Jul 29, 2021 – On 22 July 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Imatinib Koanaa, intended for the treatment of leukaemia and gastrointestinal stromal tumours. The applicant for this medicinal product is Koanaa … (leggi tutto)

British generics manufacturers call for Northern Ireland supply to be sorted

Jul 28, 2021 – In a statement Mark Samuels, Chief Executive of the British Generic Manufacturers Association (BGMA), called on the UK Government and European Union to find a solution to medicines supply for Northern Ireland. Samuels emphasised that the lack of a “stable agreement” had forced companies “to put on notice over 2,000 medicines for withdrawal from Northern Ireland” … (leggi tutto)

Risk Assessment for On-Site Inspections

Jul 28, 2021 – Due to the pandemic-related travel restrictions, supervising authorities are currently mostly carrying out so-called distant assessments. However, most inspectorates also carry out partial on-site inspections, sometimes even unannounced. The PIC/S has now developed a “Covid-19 Risk Assessment for National Routine On-Site Inspections”. This risk assessment is based on … (leggi tutto)

Regulator warns against purchasing inaccurate infrared thermometers

Jul 27, 2021 – The Medicines and Healthcare products Regulatory Agency (MHRA) is warning the public and healthcare professionals to take care when buying infrared thermometers and to know what to look for when purchasing online. There has been an increase in the number of unreliable infrared thermometers which are available in the UK. Infrared thermometers, like all … (leggi tutto)

Acting as a Responsible Person (import) (RPi): MHRA concretises Eligibility Criteria

Jul 27, 2021 – Since 1 January 2021, a wholesale dealer in Great Britain may only import Qualified Person (QP) certified medicines from the European Economic Area if certain checks are made by the Responsible Person (import) (RPi). Last year, the Medicines and Healthcare products Regulatory Agency (MHRA) has published a Guidance called “Acting as a Responsible Person … (leggi tutto)

European GDP Association nominates Alfred Hunt as new Advisory Board Member and Deputy Chair

Jul 27, 2021 – The European GDP Association, representing about 3.500 professionals from across the globe, has extended its Board. Alfred Hunt was invited to join the Advisory Board and accepted to take over the role as a Deputy Head. Alfred Hunt has extensive experience in various roles in both medicinal products and medical devices. He is a consultant working in the GDP and … (leggi tutto)

Withdrawal of Application to Change the Marketing Authorisation for Atezolizumab

Jul 26, 2021 – The European Medicines Agency (EMA) informed on 23 July 2021 that Roche Registration GmbH withdrew its application for the use of atezolizumab to treat early or locally advanced triple-negative breast cancer (TNBC). The company withdrew the application on 23 June 2021. Atezolizumab is a cancer medicine for treating urothelial cancer, lung cancer, hepatocellular carcinoma … (leggi tutto)

Dall’FDA


 

FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health

Aug 26, 2021 – Today, the U.S. Food and Drug Administration issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products after determining the applications for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the … (leggi tutto)

FDA Green Lights Companion Diagnostic for Ivosidenib in IDH1-Mutant Cholangiocarcinoma

Aug 26, 2021 – The FDA has approved the Oncomine Dx Target Test, developed by Thermo Fisher Scientific, for use as a companion diagnostic to identify patients with IDH1-mutated cholangiocarcinoma who may be eligible to receive the newly approved IDH1 inhibitor ivosidenib. The regulatory decision was based on data from the phase 3 ClarIDHy trial (NCT02989857), which showed that … (leggi tutto)

FDA Approves Ivosidenib for IDH1-Mutated Cholangiocarcinoma

Aug 25, 2021 – The FDA has approved ivosidenib for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation, as detected by an FDA-approved test. The regulatory decision was supported by findings from the phase 3 ClarIDHy study (NCT02989857), which demonstrated a statistically significant improvement … (leggi tutto)

Silmitasertib Gets Fast Track Status for Recurrent Sonic Hedgehog–Driven Medulloblastoma

Aug 25, 2021 – The FDA has granted a fast track designation to the highly selective CK2 inhibitor silmitasertib (CX-4945) as a potential therapeutic option for patients with recurrent sonic hedgehog (SHH)–driven medulloblastoma, according to an announcement from Senhwa Biosciences, Inc. CK2 is a protein kinase that has elevated activity in several cancers and a key role in DNA damage … (leggi tutto)

FDA Grants Priority Review to Asciminib for Chronic Myeloid Leukemia

Aug 25, 2021 – The FDA has granted priority review to a new drug application (NDA) seeking the approval of asciminib (ABL001) for the treatment of patients with chronic myeloid leukemia (CML). The NDA is supported by data from the phase 3 ASCEMBL trial (NCT03106779), in which the STAMP inhibitor showcased a statistically significant and clinically meaningful improvement … (leggi tutto)

FDA Issues Warning on Utilization of Robotically-Assisted Surgical Devices in Mastectomy

Aug 24, 2021 – The FDA issued an updated safety communication to remind the community that the safety and effectiveness of robotically-assisted surgical devices for use in mastectomy procedures or in the prevention or treatment of patients with breast cancer have not been established. Moreover, the regulatory agency noted that they are aware of allegations that certain clinical … (leggi tutto)

FDA Grants Priority Review to Abatacept for Prevention of Acute GVHD

Aug 23, 2021 – The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) seeking the approval of abatacept for the prevention of moderate to severe acute graft-versus-host disease (aGVHD) in patients aged 6 years and older who are receiving unrelated donor hematopoietic stem cell transplantation. The application is supported by … (leggi tutto)

FDA Approves First COVID-19 Vaccine

Aug 23, 2021 – Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age … (leggi tutto)

FDA Approves Adjuvant Nivolumab for High-Risk Urothelial Carcinoma

Aug 20, 2021 – The FDA has approved nivolumab for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, irrespective of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status. The regulatory decision is based on data from the phase 3 CheckMate-274 trial (NCT02632409), in which the … (leggi tutto)

FDA Green Lights First Companion Diagnostic for Dostarlimab in dMMR Solid Tumors

Aug 18, 2021 – The FDA has approved the VENTANA MMR RxDx panel as the first companion diagnostic test to assist in identifying patients with solid tumors that are DNA mismatch repair deficient (dMMR) who may be eligible to receive the anti–PD-1 therapy dostarlimab-gxly, which was recently granted an accelerated approval by the agency. Dostarlimab is now indicated for adult … (leggi tutto)

FDA Grants Fast Track Designation to STRO-002 for Advanced Ovarian Cancer

Aug 18, 2021 – The FDA has granted a fast track designation to STRO-002 as a potential therapeutic option for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received 1 to 3 lines of systemic therapy. The folate receptor α (FolRα)–targeting antibody-drug conjugate (ADC) is under examination in the phase 1 STRO-002-GM1 … (leggi tutto)

Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

Aug 18, 2021 – Today, public health and medical experts from the U.S. Department of Health and Human Services (HHS) released the following statement on the Administration’s plan for COVID-19 booster shots for the American people. The statement is attributable to Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC); Dr. Janet Woodcock, Acting … (leggi tutto)

FDA Approves Dostarlimab-gxly for dMMR Recurrent or Advanced Solid Tumors

Aug 17, 2021 – The FDA has granted an accelerated approval to dostarlimab-gxly for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, who have progressed on or following previous treatment and who have no satisfactory alternative options. The regulatory decision is supported by … (leggi tutto)

FDA Grants Orphan Drug Status to LP-184 for Pancreatic Cancer

Aug 17, 2021 – The FDA has granted an orphan drug designation to LP-184 as a potential therapeutic option for patients with pancreatic cancer, according to an announcement from Lantern Pharma. The next-generation alkylating agent was designed to preferentially damage DNA in cancer cells that overexpress certain biomarkers or that harbor mutations in DNA repair pathways. The … (leggi tutto)

FDA Grants CAR T-cell Therapy ALLO-715 Orphan Drug Status for Multiple Myeloma

Aug 17, 2021 – The FDA has granted an orphan drug designation to the allogeneic CAR T-cell therapy ALLO-715 for the treatment of patients with multiple myeloma, according to an announcement from Allogene Therapeutics, Inc., the drug developer. Data from the ongoing phase 1 UNIVERSAL trial (NCT04093596) demonstrated that when the therapy was administered at the 320 … (leggi tutto)

FDA Grants Orphan Drug Designation to CFT7455 for Multiple Myeloma

Aug 16, 2021 – The FDA has granted an orphan drug designation to CFT7455, a MonoDAC degrader targeting IKZF1/3, for use as a potential therapeutic option in patients with multiple myeloma, according to an announcement from C4 Therapeutics, Inc. “We are pleased to receive FDA’s orphan drug designation for CFT7455 in multiple myeloma and believe this designation highlights the … (leggi tutto)

FDA Grants Fast Track Status to IN10018 for Platinum-Resistant Ovarian Cancer

Aug 16, 2021 – The FDA has granted a fast track designation to IN10018 as a potential therapeutic option for use in patients with platinum-resistant ovarian cancer, according to an announcement from InxMed Co., Ltd. A potent and selective ATP-competitive FAK small molecule inhibitor, IN10018 is currently under development in the United States, as well as Australia, and China. Early data … (leggi tutto)

FDA Issues a Complete Response Letter for Oportuzumab monatox-qqrs for High-Risk, BCG-Unresponsive NMIBC

Aug 16, 2021 – The FDA has issued a complete response letter (CRL) to Sesen Bio regarding its biologics license application (BLA) for oportuzumab monatox-qqrs for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). The regulatory agency has determined that it cannot give the green light to the application in its present … (leggi tutto)

FDA Approves Belzutifan for Cancers Linked With Von Hippel-Lindau Disease

Aug 13, 2021 – The FDA has approved belzutifan for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET) that do not require immediate surgery. The approval was based on findings from the ongoing … (leggi tutto)

FDA Grants Breakthrough Therapy Designation for Toripalimab for Frontline Nasopharyngeal Carcinoma

Aug 12, 2021 – The FDA has granted a breakthrough therapy designation to toripalimab for single-agent use in combination with gemcitabine and cisplatin in the frontline treatment of patients with recurrent or metastatic nasopharyngeal carcinoma. The designation was supported by findings from the phase 3 JUPITER-02 trial (NCT03581786), which showed that the addition of … (leggi tutto)

FDA Approves Pembrolizumab Plus Lenvatinib for Frontline Advanced RCC

Aug 12, 2021 – The FDA has approved pembrolizumab plus lenvatinib for the frontline treatment of adult patients with advanced renal cell carcinoma. The regulatory decision is supported by data from the phase 3 CLEAR/KEYNOTE-581 trial (Study 307; NCT02811861), in which the doublet demonstrated statistically significant improvements in terms of progression-free survival … (leggi tutto)

FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals

Aug 12, 2021 – Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered … (leggi tutto)

FDA Approval Sought for Single-Agent Pembrolizumab for Select MSI-H/dMMR Advanced Endometrial Carcinoma

Aug 10, 2021 – The FDA has accepted a new supplemental biologics license application (sBLA) that is seeking the approval of pembrolizumab for use as a monotherapy in patients with advanced endometrial carcinoma that is microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR), who have progressed after systemic therapy in any setting and are not eligible for curative … (leggi tutto)

FDA Grants Priority Review to Adjuvant Pembrolizumab for Post-Nephrectomy RCC

Aug 10, 2021 – The FDA has granted priority review to a new supplemental biologics license application (sBLA) for pembrolizumab as an adjuvant treatment in patients with renal cell carcinoma (RCC) who are at intermediate-high or high risk of recurrence after nephrectomy or following nephrectomy and resection of metastatic lesions. The application is supported by data from the pivotal … (leggi tutto)

FDA Finalizes Guidance on MFS as End Point for Prostate Cancer Clinical Trials

Aug 10, 2021 – The FDA has finalized guidance on the use of metastasis-free survival (MFS) as an end point in clinical trials for nonmetastatic castration-resistant prostate cancer (CRPC). Nonmetastatic CRPC is defined by rising prostate-specific antigen (PSA) despite levels of testosterone without radiographic evidence of metastatic disease. Patients continue to experience rising PSA … (leggi tutto)

FDA Places Partial Clinical Hold on Trials Examining Eprenetapopt/Azacitidine for Myeloid Malignancies

Aug 6, 2021 – The FDA has placed a partial clinical hold on clinical trials examining the combination of eprenetapopt and azacitidine in patients with myeloid malignancies, according to an announcement from Aprea Therapeutics, Inc. The hold does not apply to the biopharmaceutical company’s ongoing clinical trials that are examining the agent in patients with lymphoid malignancies … (leggi tutto)

FDA Issues a Complete Response Letter for Eflapegrastim for Chemo-Induced Neutropenia

Aug 6, 2021 – The FDA has issued a complete response letter to Spectrum Pharmaceuticals regarding the biologics license application (BLA) for eflapegrastim as a potential option for the management of chemotherapy-induced neutropenia. In the letter, the regulatory agency cited deficiencies associated with the manufacturing of the agent and specified that a reinspection will be needed … (leggi tutto)

FDA Grants Orphan Drug Designation to Sotigalimab for Soft Tissue Sarcoma

Aug 5, 2021 – The FDA has granted an orphan drug designation to sotigalimab (APX005M) as a potential therapeutic option for patients with soft tissue sarcoma, according to announcement from Apexigen Inc., the drug developer. A novel, humanized monoclonal antibody, sotigalimab was designed stimulate antitumor immune response and to target CD40, which is a key co- … (leggi tutto)

FDA Grants Priority Review to Adjuvant Pembrolizumab for Stage II High-Risk Melanoma

Aug 5, 2021 – The FDA has granted priority review to a supplemental biologics license application (sBLA) for pembrolizumab for the use as an adjuvant treatment in adult and pediatric patients with stage IIB or IIC melanoma following complete resection. The application is supported by data from the phase 3 KEYNOTE-716 trial (NCT03553836), which demonstrated that adjuvant … (leggi tutto)

FDA Grants Priority Review to Cabozantinib for Radioiodine-Refractory Differentiated Thyroid Cancer

Aug 5, 2021 – The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for cabozantinib for use in the treatment of patients aged 12 years and older with differentiated thyroid cancer who have progressed after previous therapy and who are radioactive iodine refractory. The application is supported by data from the phase 3 COSMIC-311 trial (NCT03690388) … (leggi tutto)

FDA Grants Priority Review to Adjuvant Atezolizumab for PD-L1+ Early-Stage NSCLC

Aug 3, 2021 – The FDA has granted priority review to a supplemental biologics license application (sBLA) for atezolizumab as an adjuvant treatment after surgery and platinum-based chemotherapy in patients with non–small cell lung cancer (NSCLC) whose tumors have a PD-L1 expression of 1% or higher per an FDA-approved test. The application is supported by findings from the phase 3 … (leggi tutto)

FDA Grants Fast Track Status to Nemvaleukin Alfa for Mucosal Melanoma

Aug 2, 2021 – The FDA has granted a fast track designation to the interleukin-2 (IL-2) variant immunotherapy nemvaleukin alfa as a potential therapeutic option for patients with mucosal melanoma, according to an announcement from Alkermes plc, the drug developer. The investigational, engineered fusion protein is made up of modified IL-2 and the high affinity IL-2 alpha receptor … (leggi tutto)

FDA approve emergency use of casirivimab and imdevimab for COVID-19 prevention

Aug 2, 2021 – The US Food and Drug Administration (FDA) have revised the emergency use authorisation (EUA) for casirivimab and imdevimab, administered together, authorising it for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and paediatric individuals who are at high risk for progression to severe COVID-19. Casirivimab and imdevimab … (leggi tutto)

FDA Grants Fast Track Status to Eryaspase for Hypersensitive Acute Lymphocytic Leukemia

Jul 30, 2021 – The FDA has granted a fast track designation to eryaspase for use as a potential therapeutic option in patients with acute lymphocytic leukemia (ALL) who have developed hypersensitivity reactions to Escherichia coli–derived pegylated asparaginase. Eryaspase consists of L-asparaginase encapsulated inside donor-derived red blood cells, and it was designed to target altered … (leggi tutto)

FDA Warns of Increased Risk of Death With Melphalan Flufenamide in Multiple Myeloma

Jul 29, 2021 – The FDA has issued an alert that evidence from the phase 3 OCEAN study (NCT03151811) of melphalan flufenamide (melflufen), which was recently approved for use in combination with dexamethasone in patients with relapsed or refractory multiple myeloma, has indicated that the doublet resulted in an increased risk of death in this population. In the multicenter, open-label … (leggi tutto)

FDA Warns Firm with Over 15 Million Products Listed with FDA to Remove Unauthorized E-Cigarette Products from Market

Jul 28, 2021 – The following quote is attributed to Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products: “Today, the FDA issued a warning letter to a company with over 15 million tobacco products listed with the FDA, including many flavored e-liquids, for illegally marketing electronic nicotine delivery system (ENDS) products without authorization. This action demonstrates the … (leggi tutto)

FDA Approves Pembrolizumab for High-Risk Early-Stage TNBC Plus Chemo as Neoadjuvant Treatment, Then as Single-Agent Adjuvant Treatment

Jul 27, 2021 – The FDA has approved pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. The regulatory decision is based on data from the phase 3 KEYNOTE-522 trial (NCT03036488), which showed … (leggi tutto)

FDA Grants Priority Review to Nab-Sirolimus for Advanced Malignant PEComa

Jul 26, 2021 – The FDA has granted priority review to a new drug application (NDA) for the nanoparticle albumin-bound mTOR inhibitor nab-sirolimus (ABI-009) for the treatment of patients with malignant perivascular epithelioid cell neoplasm (PEComa). The application is based on findings from the AMPECT registration trial (NCT02494570), which showed that the agent elicited highly durable … (leggi tutto)

FDA Issues a Complete Response Letter for Retifanlimab for Squamous Cell Carcinoma of the Anal Canal

Jul 26, 2021 – The FDA has issued a complete response letter to Incyte Corporation stating that it cannot approve the biologics license application (BLA) for retifanlimab (INCMGA 0012) for use in adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy, in its … (leggi tutto)

Dall’ASCO


 

ASCO Roadmap Provides Path Forward for Clinician Well-Being

Aug 20, 2021 – Educational program aimed at implementing systemic-level changes may provide oncology care providers with the necessary tools to mitigate the increasing prevalence of burnout. A collaborative initiative between the American Society of Clinical Oncology (ASCO) and the American Medical Association (AMA) has the goal of improving well-being and reducing burnout … (leggi tutto)

Studies on Access to Cancer Care and Treatment to be Highlighted in 2021 ASCO Quality Care Symposium Press Program

Aug 17, 2021 – Research covering cancer treatment delays due to insurance type, and improvements in cancer care and quality of life for low-income and minority patients seen with integrated community-based interventions will be highlighted in the 2021 American Society of Clinical Oncology (ASCO) Quality Care Symposium’s official Press Program. Studies featured in the Press Program … (leggi tutto)

ASCO Applauds Administration Decision to Withdraw Most Favored Nation Model

Aug 6, 2021 – “The Association for Clinical Oncology (ASCO) commends the Biden Administration for proposing to rescind the Most Favored Nation (MFN) model from consideration. ASCO has consistently opposed the ill-advised MFN model, as it would have had a devastating impact on people with cancer. “The proposed MFN model would have imposed a nationwide, mandatory experiment … (leggi tutto)

ASCO 2021 Delivers Personalized Treatment Approaches Across Breast Cancer

Aug 6, 2021 – Refining treatment, either through escalated or de-escalated strategies, is not only a key aim of research in breast cancer but a greater possibility in the clinic with neoadjuvant and adjuvant PARP inhibitors, HER2 monoclonal antibodies, and greater stratification of genomic risk, as seen in findings from several trials presented at the 2021 ASCO Annual Meeting, explained … (leggi tutto)

Revised Children’s Oncology Group Neuroblastoma Risk Classification System

Aug 4, 2021 – As reported in the Journal of Clinical Oncology by Irwin et al, the Children’s Oncology Group (COG) has developed a new neuroblastoma risk classification (COG version 2) that uses the International Neuroblastoma Risk Group Staging System (INRGSS) and incorporates segmental chromosome aberrations as an additional biomarker. As noted by the investigators, the most … (leggi tutto)

Expert Point of View: Giuseppe Curigliano, MD, PhD

Aug 2, 2021 – Invited discussant Giuseppe Curigliano, MD, PhD, Associate Professor of Medical Oncology at the University of Milan, Italy, and Head of the Division of Early Drug Development at the European Institute of Oncology, said the “clear” findings of KEYNOTE-5221 are “practice-changing.” However, the ideal patient for neoadjuvant pembrolizumab plus chemotherapy … (leggi tutto)

ASTRO Issues New Clinical Guideline on Radiation Therapy for Adult Patients With Soft-Tissue Sarcoma

Jul 29, 2021 – A new clinical guideline from the American Society for Radiation Oncology (ASTRO) published by Kilian E. Salerno, MD, and colleagues in Practical Radiation Oncology provides guidance on the use of radiation therapy to treat adult patients with soft-tissue sarcomas. Recommendations outline optimal radiation dosing, techniques, and treatment planning for patients with … (leggi tutto)

Survival Trends for Adolescents and Young Adults With Cancer: 40-Year Analysis

Jul 28, 2021 – Survival rates for adolescents and young adults diagnosed with cancer vary considerably depending on the type of malignancy. A new study published by Riedel Lewis et al in the journal Cancer indicated that survival for multiple cancer types in such patients has improved in recent years, but some patients diagnosed with common cancer types still show limited survival improvements … (leggi tutto)

Cancer vs Non–Cancer-Related Deaths Among Older Patients Selected for Surgical Treatment

Jul 27, 2021 – In a Canadian population-based cohort study reported in JAMA Surgery, Chesney et al found that the 5-year rate of cancer-related deaths exceeded that of non–cancer-related deaths among patients aged 70 or older undergoing surgery for cancer. The study used data from ICES (formerly Institute for Clinical Evaluative Sciences) on all patients aged 70 and older who … (leggi tutto)

Global Estimates of New Cancers Attributable to Alcohol Use in 2020

Jul 27, 2021 – In a population-based study reported in The Lancet Oncology, Rumgay et al provided estimates of the global incidence of new cancers attributable to alcohol consumption, including the estimate that 4.1% of all new cases in 2020 were related to alcohol use. In the study, population attributable fractions derived using a theoretical minimum-risk exposure of lifetime abstention and … (leggi tutto)

Nel mondo


 

Pembrolizumab Approved in Japan for Select Breast Cancer and Colorectal Cancer

Aug 26, 2021 – The Japan Pharmaceuticals and Medical Devices Agency has approved the use of pembrolizumab in the treatment of patients with PD-L1–positive, hormone receptor–negative and HER2-negative, inoperable or recurrent breast cancer, and for single-agent use in patients with unresectable, advanced, or recurrent microsatellite instability–high (MSI-H) colorectal … (leggi tutto)

Cabozantinib Plus Nivolumab Approved in Japan for Unresectable or Metastatic RCC

Aug 26, 2021 – The Japanese Ministry of Health, Labor, and Welfare has approved the combination of cabozantinib and nivolumab for the treatment of patients with unresectable or metastatic renal cell carcinoma (RCC). The regulatory decision was based on data from the phase 3 CheckMate-9ER trial (NCT03141177), which showed that the median progression-free survival … (leggi tutto)

NCCN Calls for Mandatory COVID-19 Vaccination for Healthcare Workers

Aug 23, 2021 – The National Comprehensive Cancer Center Network (NCCN) has issued an official statement calling on all healthcare systems to ensure that their workforces are immunized with one of the authorized COVID-19 vaccines. Because patients with cancer are known to be more susceptible to experiencing complications from COVID-19, and certain populations may not mount … (leggi tutto)

Dana-Farber Cancer Institute Establishes the David Liposarcoma Research Initiative

Aug 19, 2021 – Dana-Farber Cancer Institute announced that The Rossy Foundation has committed $10 million to establish the David Liposarcoma Research Initiative. The five-year initiative will spearhead groundbreaking research into liposarcoma at Dana-Farber and external collaborating partner institutions, with the aim of transforming the treatment of this rare, underfunded … (leggi tutto)

ACCC Report: Immunotherapy Research Grew in 2020 Despite COVID-19 Pandemic

Aug 7, 2021 – The COVID-19 pandemic had a relatively limited effect on immuno-oncology (IO) research, according to results from the Association of Community Cancer Centers (ACCC) fourth annual analysis of the IO landscape. As of August 2020, there were 4720 IO agents and 504 targets under investigation in more than 6200 active clinical trials as of August 2020, a 22% … (leggi tutto)

Memorial Sloan Kettering Cancer Center Launches MSKCC India to Expand Access to World-Renowned Oncologists, Cancer Care, Research, and Education

Aug 3, 2021 – Memorial Sloan Kettering Cancer Center, the world’s oldest and largest private cancer center, has launched MSKCC India to provide cancer patients in India with access to the institution’s world-renowned oncologists, research, clinical trials, and education. The effort stems from the institution’s core mission of advancing transformative cancer care through education and … (leggi tutto)

New WHO Draft on GMP for IMPs

Jul 29, 2021 – Last year the WHO published draft documents on “Good manufacturing practices for investigational products” (GMP for IMPs) and “Good practices for research and development facilities”. After consolidation of comments received and review of feedback, revised versions of the two guidelines have now been published for a second round of public consultation. The deadline for … (leggi tutto)

Joseph W. Kim Receives Prestigious 2021 Cancer Clinical Investigator Team Leadership Award

Jul 28, 2021 – Joseph W. Kim, MD, Associate Professor of Medicine (Medical Oncology) at Yale Cancer Center, has received a 2021 Cancer Clinical Investigator Team Leadership Award (CCITLA) from the National Cancer Institute (NCI). The award recognizes and supports outstanding mid-career clinical investigators at NCI-designated cancer centers who are working to improve the lives of … (leggi tutto)

Zanubrutinib Approved in Canada for MCL

Jul 26, 2021 – Health Canada has approved the BTK inhibitor zanubrutinib for use in the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received at least 1 therapy, according to an announcement from BeiGene, Ltd. The regulatory decision is based on data from 2 single-arm clinical trials. Across the trials, zanubrutinib elicited an overall response rate (ORR) of … (leggi tutto)

Pillole dall’AIFA


 
27 agosto 2021 – Monitoraggio anticorpi monoclonali per COVID-19: pubblicato il ventunesimo report 

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27 agosto 2021 – Liste sostanze attive – generici (aggiornamento) 

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25 agosto 2021 – Dopo reazioni avverse gravi a carico della sfera coagulativa con prima dose di vaccino COVID-19 AstraZeneca possibile richiamo con vaccino a m-RNA anche negli ultra sessantenni 

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23 agosto 2021 – Registri AIFA: informazioni sui dati dei trattamenti con i nuovi farmaci per la cura dell’epatite C 

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20 agosto 2021 – AIFA smentisce fake news: le autorizzazioni dei vaccini anti-COVID restano valide 

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10 agosto 2021 – Modifiche Registro – anticorpi monoclonali COVID-19 

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5 agosto 2021 – Definizione delle modalità ottimali d’uso degli anticorpi monoclonali anti COVID-19 

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5 agosto 2021 – Modifica – Registro Lenalidomide (Bristol-Myers Squibb) (NDMM) mantenimento post-ASCT 

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5 agosto 2021 – I dati del Rapporto OsMed 2020 in modalità interattiva 

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4 agosto 2021 – Aggiornamento ECDC – EMA su COVID-19 

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4 agosto 2021 – Settimo Rapporto AIFA sulla sorveglianza dei vaccini COVID-19 

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4 agosto 2021 – Chiusura Registro di monitoraggio Plerixafor (Genzyme) 

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4 agosto 2021 – Chiusura Managed Entry Agreements (MEA) Registro Plerixafor (Genzyme) 

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3 agosto 2021 – Attivazione web e pubblicazione schede di monitoraggio – Registro Lorlatinib (Pfizer) (NSCLC) 

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2 agosto 2021 – Monitoraggio della spesa farmaceutica 

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2 agosto 2021 – Sei mesi al lancio del sistema informativo sulle sperimentazioni cliniche (CTIS) 

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30 luglio 2021 – Estensione del silenzio assenso nelle procedure post-autorizzative. Determina AIFA DG N. 880/2021 

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30 luglio 2021 – Chiusura Registro di monitoraggio Axitinib (Pfizer) 

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30 luglio 2021 – Chiusura Managed Entry Agreements (MEA) Registro Axitinib (Pfizer) 

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29 luglio 2021 – Notifica dei provvedimenti – Ufficio Ispezioni e Autorizzazioni GMP Medicinali 

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29 luglio 2021 – Revisione sulle nitrosammine. Comunicazione alle aziende sugli Step 2 e 3 

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29 luglio 2021 – Comunicazione sulla gestione richieste Fondo 5% per il periodo estivo 

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28 luglio 2021 – Aggiornamento del Report tecnico-scientifico AIFA su Axicabtagene ciloleucel (Kite Pharma) 

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28 luglio 2021 – AIFA approva l’utilizzo del vaccino Moderna per la fascia di età 12-17 anni 

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27 luglio 2021 – Nuove Funzionalità: Presa in carico, Modifica anagrafica, DF sospese 

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27 luglio 2021 – Farmaci biosimilari in Italia: report AIFA aggiornati a marzo 2021 

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27 luglio 2021 – Proroga modifiche straordinarie autorizzazione convegni e congressi 

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26 luglio 2021 – Tabelle farmaci di classe A e H al 17/02/2021 

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A causa del protrarsi dell’emergenza coronavirus e delle relative disposizioni, si suggerisce di verificare la conferma dei singoli eventi direttamente con gli organizzatori  


XXIII CONGRESSO NAZIONALE AIOM 2021
Per un’oncologia di valore dalla prevenzione al trattamento
Virtual Edition, 22 – 24 ottobre 2021
Evento Nazionale AIOM
Link all’evento


IJOURNEY
Percorso di Formazione in tema di Breast Cancer
FAD, 1 marzo – 1 settembre 2021 
Iscrizioni aperte per tutta la durata del corso
Evento patrocinato da AIOM
Link all’evento  

SUPPORTIVE CARE: The Big One 
FAD, 14 settembre 2020 – 14 settembre 2021 
Iscrizioni aperte per tutta la durata del corso
Evento Nazionale AIOM
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NUOVE STRATEGIE TERAPEUTICHE NEL TRATTAMENTO DEL CARCINOMA OVARICO
FAD, 5 aprile – 5 ottobre 2021 
Evento patrocinato da AIOM
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e-NUTRACARE
Presa in carico multidisciplinare del paziente oncologico a rischio malnutrizione:
Modello pilota di collegamento tra oncologo e nutrizionista
Virtual Meeting, 14 giugno – 8 ottobre 2021 
Evento patrocinato da AIOM 
Link all’evento

COME CAMBIA IL TRATTAMENTO DELLA NEOPLASIA TRIPLO-NEGATIVA METASTATICA
FAD asincrona, 20 aprile – 20 ottobre 2021 
Evento patrocinato da AIOM
Link all’evento

IL TRATTAMENTO DEI TUMORI LUMINALI DELLA MAMMELLA
Stato dell’Arte e Prospettive Future
Aggiornamenti in Oncologia 
FAD asincrona, 15 giugno – 30 novembre 2021 
Evento patrocinato da AIOM
Link all’evento

UPDATE SUI TUMORI DEL RENE
Aggiornamenti in Oncologia
FAD asincrona, 30 giugno – 30 novembre 2021 
Evento patrocinato da AIOM
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CDK4/6 INHIBITORS – EVOLUTION OF THE PARADIGM 
FAD, 28 giugno – 28 dicembre 2021 
Evento patrocinato da AIOM
Link all’evento

NSCLC AVANZATO ONCOGENE-ADDICTED: STATO DELL’ARTE E PROSPETTIVE 
FAD, 17 maggio 2021 – 16 maggio 2022 
Evento patrocinato da AIOM
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IL CARCINOMA GASTRICO: NUOVE OPPORTUNITÀ E NUOVE PROBLEMATICHE 
FAD, 21 maggio 2021 – 20 maggio 2022 
Evento patrocinato da AIOM
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L’ADROTERAPIA E L’IMPORTANZA DELLA MULTIDISCIPLINARIETÀ PER UNA TERAPIA PERSONALIZZATA
FAD, 15 giugno 2021 – 15 giugno 2022 
Evento patrocinato da AIOM
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LANDSCAPES IN ONCOLOGIA 2021
Precision Medicine – Targeted therapy e immunoterapia
FAD, 1 luglio 2021 – 30 giugno 2022 
Evento patrocinato da AIOM
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GESTIONE MULTIDISCIPLINARE DELLE NEOPLASIE GINECOLOGICHE:
Nuovi trattamenti farmacologici e radioterapici
FAD, settembre 2021 – settembre 2022 
Evento patrocinato da AIOM
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LUNG CANCER
Cocktail With Science
FAD, 2 settembre 2021 
Evento patrocinato da AIOM
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LA MEDICINA DI PRECISIONE: TRA TARGETED THERAPY ED IMMUNOTERAPIA
III Edizione
FAD, 3 settembre 2021 
Evento patrocinato da AIOM
Link all’evento

PRECISION AND INNOVATION IN ONCOLOGY
EGFR, ALK, RAS AND BRAF Pathway Inhibition
FAD, 6 settembre 2021 
Evento Webinar a cura della Sezione Regionale AIOM Toscana 
Link all’evento

STUDI CLINICI: METODOLOGIA
4° Modulo. Comunicare (dalla stesura condivisa del protocollo alla comunicazione durante gli eventi scientifici)
Negrar di Valpolicella (VR), 7 – 8 settembre 2021 
Evento patrocinato da AIOM
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L’INNOVAZIONE NELLA PREVENZIONE DELL’HERPES ZOSTER
I mercoledì dell’oncologia
Webinar, 8 settembre 2021 
Evento Nazionale AIOM 
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BIOMARKERS SUMMIT IN GYNECOLOGICAL CANCERS
Webinar, 9 settembre 2021 
Evento patrocinato da AIOM
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INCONTRO SUL TRATTAMENTO DELLA PAZIENTE ANZIANA AFFETTA DA CARCINOMA MAMMARIO
Dai dati della letteratura alla pratica clinica
Webinar, 9 settembre 2021 
Evento patrocinato da AIOM
Link all’evento

PDTA REGIONALI IN ONCOLOGIA:
Il Ruolo del Farmacista e dell’Oncologo
Campania/Sicilia
Webinar, 10 settembre 2021 
Evento macro-regionale patrocinato da AIOM
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INNOVATORS IN BREAST CANCER 2021
3a Edizione
Novara, 10 – 11 settembre 2021 
Evento patrocinato da AIOM
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NEN PRECEPTORSHIP IX Edizione
La pratica clinica nelle neoplasie neuroendocrine
Milano, 13 -14 settembre 2021 
Evento patrocinato da AIOM
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MEET THE PROFESSORS:
Incontri Monografici sul Carcinoma Prostatico
Webinar, 13 settembre, 11 ottobre, 8 e 29 novembre, 20 dicembre 2021 
Evento patrocinato da AIOM
Link all’evento

INCONTRI DI AGGIORNAMENTO DEI CENTRI DI SENOLOGIA DELLA EMILIA ROMAGNA
Ciclo di incontri Webinar – Oxford Debates in Breast Cancer
Webinar, 13 settembre, 18 ottobre, 8 novembre e 2021 
Patrocinio concesso dalla Sezione Regionale AIOM Emilia Romagna 
Link all’evento

PDTA REGIONALI IN ONCOLOGIA:
Il Ruolo del Farmacista e dell’Oncologo
Puglia/Calabria
Webinar, 14 settembre 2021 
Evento macro-regionale patrocinato da AIOM
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NUOVI SCENARI NEL TRATTAMENTO DEL CARCINOMA PROSTATICO AVANZATO E DEL BONE HEALTH
Webinar, 14 settembre 2021 
Evento patrocinato da AIOM
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IMMUNOTERAPIA: WHAT’S NEW?
I mercoledì dell’oncologia
Webinar, 15 settembre 2021 
Evento Nazionale AIOM 
Link all’evento

ACCESSO AI FARMACI E SOSTENIBILITÀ IN ONCOLOGIA:
Da Molecular Tumor Board alla Medicina di Precisione
Roma, 15 settembre 2021 
Convegno Regionale AIOM Marche
Link all’evento

2° CONVEGNO SEX AND THE CANCER
Quello che le donne non dicono
Roma, 15 settembre 2021 
Evento patrocinato da AIOM
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e-NUTRACARE
Analisi del processo di supporto nutrizionale al paziente oncologico: condivisione del Modello Pilota
Webinar, 15 settembre 2021 
Evento patrocinato da AIOM
Link all’evento

VIRTUAL PRECEPTORSHIP IN ONCOLOGIA TESTA COLLO 
Carcinomi di Orofaringe e a Primitività Ignota
Webinar, 16 settembre 2021 
Evento patrocinato da AIOM
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NUTRIZIONE IN ONCOLOGIA
Webinar, 17 settembre 2021 
Evento patrocinato da AIOM
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IL DOMANI È GIÀ QUI: UNA FINESTRA SUL FUTURO DELL’ONCOLOGIA LIGURE
Genova, 18 settembre 2021 
Convegno Regionale AIOM Liguria
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MULTIDISCIPLINARY CANCER MEETING: IMPARIAMO A CONFRONTARCI
FAD, 20 – 22 settembre 2021 
Convegno Regionale AIOM Puglia
Link all’evento

IL MELANOMA CUTANEO BRAF MUTATO: 
“REAL LIFE” E NUOVE STRATEGIE TERAPEUTICHE
FAD, 21 settembre 2021 
Evento patrocinato da AIOM
Link all’evento

UPDATE SUI CDK4/6i NELLA MALATTIA ENDOCRINOSENSIBILE
I mercoledì dell’oncologia
Webinar, 22 settembre 2021 
Evento Nazionale AIOM 
Link all’evento

STUDI CLINICI: METODOLOGIA
5° Modulo. Come scrivere un protocollo di ricerca clinica
Negrar di Valpolicella (VR), 22 – 23 settembre 2021 
Evento patrocinato da AIOM
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CONTROVERSIES IN GENITOURINARY TUMORS 2021
Prostate cancer
Webinar, 23 settembre 2021 
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MULTIDISCIPLINARY MANAGEMENT OF CHOLANGIOCARCINOMA
COST Training School
Rozzano (MI), 23 – 24 settembre 2021 
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WHAT’S NEW IN OVARIAN AND BREAST CANCER TREATMENT
Chieti, 24 settembre 2021 
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1971 – 2021: CINQUANT’ANNI DELLA CLINICA UROLOGICA L. GIULIANI
Genova, 23 – 24 settembre 2021 
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NEOPLASIE DEL TRATTO UROGENITALE
FAD, 24 settembre 2021 
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NEOPLASIE NEUROENDOCRINE: QUI IL PATOLOGO È A CASA!
Milano, 24 settembre 2021 
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TERAPIA BIOLOGICA … ED OLTRE IN PNEUMO-ONCOLOGIA
Evento ibrido residenziale/webinar
Rovigo, 24 settembre 2021 
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IL PAZIENTE ONCOLOGICO IN PRONTO SOCCORSO
Belluno, 24 – 25 settembre 2021 
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NUTRIZIONE IN ONCOLOGIA
Pavia, 25 settembre 2021 
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CRONICITÀ E DIFFERENZE DI GENERE
5° Congresso Nazionale ONDA 2021
Live Streaming, 28 – 29 settembre 2021 
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TROMBOEMBOLISMO E CANCRO:
DALL’EPIDEMIOLOGIA ALLA GESTIONE MULTIDISCIPLINARE
I mercoledì dell’oncologia
Webinar, 29 settembre 2021 
Evento Nazionale AIOM 
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CONTROVERSIES IN GENITOURINARY TUMORS 2021
Kidney cancer and urothelial cancer
Webinar, 30 settembre 2021 
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ADVANCED INTERNATIONAL BREAST CANCER COURSE (AIBCC)
17° Meet the Professor
FAD, 30 settembre – 1 ottobre 2021 
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TUMORI DEL TRATTO GASTROINTESTINALE: TRA SCIENZA E PRATICA
X Workshop Nazionale
FAD, 30 settembre – 1 ottobre 2021 
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6° MASTER MULTIDISCIPLINARE IN ONCOLOGIA CERVICO-FACCIALE
Tumori della laringe
Webinar, 30 settembre – 1 ottobre 2021 
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8th INTERNATIONAL ADRENAL CANCER SYMPOSIUM
Webinar, 30 settembre – 2 ottobre 2021 
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XXXI CONGRESSO NAZIONALE SIUrO
Virtual Meeting, 30 settembre – 2 ottobre 2021 
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3rd BACK FROM INTERNATIONAL CONGRESSES (ESMO AND WCLC) & HOT TOPICS IN ONCOLOGY 2021
FAD, 1 ottobre 2021 
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NUOVE STRATEGIE IN IMMUNONCOLOGIA: QUALI EVIDENZE
Bologna, 1 ottobre 2021 
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CARCINOMA DELLA MAMMELLA NELLA PAZIENTE ANZIANA
XII Corso di Formazione
Roma, 1 ottobre 2021 
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NEWS IN GU ONCOLOGY 2021
Castro (LE), 1 – 2 ottobre 2021 
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CORSO DI ALTA FORMAZIONE IN ONCOFERTILITÀ 2021
FAD, 4 – 28 ottobre, 3 – 25 novembre, 1 – 21 dicembre 2021 
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CAMBIO DI PASSO NEL TRATTAMENTO DEL CARCINOMA DELL’ENDOMETRIO
I mercoledì dell’oncologia
Webinar, 6 ottobre 2021 
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MUTAZIONE BRCA: CARE & CURE
FAD, 7 ottobre 2021 
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PADOVA MEETING POST ESMO ITALY 2021
Women for Oncology
Padova, 8 ottobre 2021 
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NUTRIZIONE IN ONCOLOGIA
Webinar, 8 ottobre 2021 
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VI CORSO EUROPEO DI PSICO-ONCOLOGIA
Corso base – Corso Avanzato
FAD, 9, 16, 23 ottobre – 6, 13, 20, 27 novembre 2021 
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LARINGECTOMIA DI SALVATAGGIO
Team multidisciplinare, medicina di precisione, telemedicina
FAD, 13 ottobre 2021 
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LUNG CANCER
Cocktail With Science
FAD, 14 ottobre 2021 
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VIRTUAL XIX NIBIT MEETING
Cancer immunity and immunotherapy beyond COVID-19
FAD, 14 – 15 ottobre 2021 
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LA RICERCA E LA CURA: UPDATE 2021
Neoplasie dell’esofago, dello stomaco ed epatocarcinoma
Virtual Meeting, 15 – 16 ottobre 2021 
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XXXI CONGRESSO NAZIONALE AIRO
Bologna, 15 – 17 ottobre 2021 
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VIRTUAL PRECEPTORSHIP IN ONCOLOGIA TESTA COLLO
Carcinomi di Rinofaringe e Seni Paranasali
Webinar, 28 ottobre 2021 
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