Oggi in Oncologia   

Efficacy of Selpercatinib in RET Fusion–Positive Non–Small-Cell Lung Cancer 

RET fusions are oncogenic drivers in 1 to 2% of non-small-cell lung cancers (NSCLCs). In patients with RET fusion-positive NSCLC, the efficacy and safety of selective RET inhibition are unknown. We enrolled patients with advanced RET fusion-positive NSCLC who had previously received platinum-based chemotherapy and those who were previously untreated separately in a phase 1-2 trial of  … (leggi tutto)

Le fusioni di RET sono state identificate nell’1-2% dei pazienti con tumore polmonare non a piccole cellule e sono caratterizzate da spiccata tendenza alla metastatizzazione encefalica.¹ Queste alterazioni sono maggiormente frequenti nel sesso femminile, nei non fumatori e nelle istologie adenocarcinoma e carcinoma scarsamente differenziato.
Molecole con attività multi-target sono state testate su pazienti con alterazioni del gene RET dimostrando solo debole attività clinica, probabilmente a causa della loro bassa selettività e della maggiore tossicità dose-limitante legata alla concomitante attività inibitoria su altre chinasi.²  
In modelli pre-clinici, selpercatinib (LOXO-292) si è dimostrato un potente inibitore, altamente selettivo, contro fusioni e mutazioni puntiformi di RET, con spiccata capacità di diffusione encefalica.³  
Lo studio di fase I-II LIBRETTO-001 ha valutato sicurezza ed efficacia di selpercatinib in pazienti affetti da neoplasia solida con alterazione di RET (fusione o mutazione). I risultati relativi ai pazienti affetti da NSCLC avanzato sono stati recentemente pubblicati nella rivista New England Journal of Medicine.⁴ 
Lo studio ha arruolato pazienti affetti da NSCLC avanzato precedentemente pretrattati con chemioterapia a base di platino (n=105) e treatment-naïve (n=39). I pazienti che avevano ricevuto precedenti trattamenti sistemici erano nella maggior parte dei casi altamente pre-trattati, con una mediana di 3 trattamenti sistemici. In particolare, il 55% aveva già effettuato un trattamento con immunoterapia e il 48% aveva già ricevuto un trattamento con farmaci inibitori multi-target con attività su RET.
L’obiettivo primario dello studio era la proporzione di risposte secondo valutazione centralizzata. Gli obiettivi secondari erano: durata della risposta, sopravvivenza libera da progressione e safety.
Nei pazienti pretrattati, la proporzione di risposte obiettive era del 64% (IC 95%: 54-73) con una durata mediana della risposta di 17,5 mesi (IC 95%: 12,1-non raggiunto), il 63% di questi manteneva la risposta radiologica ad un follow-up mediano di 12 mesi. I pazienti treatment-naïve mostravano una proporzione di risposte obiettive dell’85% (IC 95%: 70-94%), con il 90% dei pazienti che manteneva la risposta ad un follow-up mediano di 6 mesi. Dieci degli 11 pazienti con lesioni encefaliche misurabili mostravano una risposta obiettiva intracranica.
Il trattamento ha mostrato un buon profilo di tollerabilità. Gli eventi avversi più comuni di grado ≥ 3 sono stati l’ipertensione (14%), l’incremento delle transaminasi (10-12%), l’iponatriemia (6%) e la linfopenia (6%).
Considerando tutti i pazienti arruolati nello studio (n=531), solo il 30% ha richiesto una riduzione della dose a causa degli eventi avversi farmaco-relati, e solo nel 2% dei pazienti è stata necessaria l’interruzione del trattamento.
La proporzione e la durata delle risposte sono in linea con quelli ottenuti con altri trattamenti target che oggi rappresentano lo standard di prima linea (inibitori di EGFR, ALK e ROS-1).
L’esperienza acquisita con gli altri trattamenti target ci ha insegnato che dati di efficacia così convincenti insieme ad un buon profilo di tossicità, rendono non necessario (oltre che di dubbia eticità) uno studio di confronto con l’attuale standard di trattamento.
Gli inibitori selettivi di RET, selpercatinib (Loxo-292) e pralsetinib (Blu-667) entrano prepotentemente nella lista dei trattamenti target che incidono in maniera netta sulla storia di malattia allargando la famiglia delle neoplasie polmonari oncogene-addicted. Questi farmaci non sono ancora disponibili nella pratica clinica ma è possibile richiederne l’uso nominale.
Il numero sempre crescente di nuovi target (RET, MET, HER-2, NTRK) e la possibilità di rapido accesso ai farmaci impongono la disponibilità in tutto il territorio di una completa diagnostica molecolare per garantire a tutti i pazienti la miglior opzione terapeutica.

1. Wang R, Hu H, Pan Y, et al. RET fusions define a unique molecular and clinicopathologic subtype of non-small-cell lung cancer. J Clin Oncol. 2012;30:4352–9
2. Yoh K, Seto T, Satouchi M, et al. Vandetanib in patients with previously treated RET-rearranged advanced non-smallcell lung cancer (LURET): an open-label, multicentre phase 2 trial. Lancet Respir Med 2017; 5: 42-50
3. Subbiah V, Velcheti V, Tuch BB, et al. Selective RET kinase inhibition for patients with RET-altered cancers. Ann Oncol 2018; 29: 1869-76
4. Drilon A, Oxnard GR, Tan DSW, et al. Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2020;383(9):813-824

The effect of advances in lung-cancer treatment on population mortality

Lung cancer is made up of distinct subtypes, including non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). Although overall mortality from lung cancer has been declining in the United States, little is known about mortality trends according to cancer subtype at the population level because death certificates do not record subtype information. Using data from Surveillance, Epidemiology, and ... (leggi tutto)

In questo lavoro, Howlader e colleghi hanno valutato la mortalità per tumore polmonare e i trends relativi.
A differenza di altri lavori simili, gli autori hanno valutato i trends di mortalità attribuiti agli specifici sottotipi (non-small-cell lung cancer [NSCLC] e small-cell lung cancer [SCLC]) utilizzando il metodo della population-level mortality. È stato utilizzato come numeratore il numero delle morti cancro-specifiche riportate nel U.S. Surveillance, Epidemiology, and End Results (SEER) Program, mentre il denominatore impiegato è stata la popolazione a rischio di morte nello stesso momento nelle aree del SEER. L’analisi è stata condotta dal 2001 al 2016.
È stato evidenziato un graduale decremento di incidenza per il NSCLC dal 2001 al 2008 (1,9% per anno; IC 95%: 1,6-2,2) seguito da una più rapida riduzione dal 2008 al 2016 (3,1% per anno , IC 95%: 2,8-3,3). Nella stessa popolazione la mortalità basata sull’incidenza si è ridotta del 3,2% all’anno (IC 95%: 2,5-4,0) dal 2006 fino al 2013, poi del 6,3% all’anno (IC 95%: 3,4-9,0) dal 2013 al 2016. La sopravvivenza a 2 anni per gli uomini con diagnosi di NSCLC è risultata di conseguenza incrementata dal 26% del 2001 al 35% del 2014. La coorte delle donne con NSCLC è stata caratterizzata da un’incidenza stabile dal 2001 al 2006, seguita da un decremento annuo dell’1,5% (IC 95%: 1,3-1,7) nei 10 anni successivi. Al contrario la mortalità basata sull’incidenza si è ridotta del 2,3% all’anno (IC 95%: 1,8-2,8) dal 2006 fino al 2014, poi del 5,9% all’anno (IC 95%: 1,3-10,2) dal 2014 al 2016. La sopravvivenza a 2 anni è incrementata di conseguenza dal 35% del 2001 al 44% del 2014.
Per quanto riguarda il SCLC, l’incidenza si è ridotta in modo simile in entrambi i sessi, mentre le curve di sopravvivenza relative sono rimaste invariate, indicando la mancanza di significativi avanzamenti terapeutici nel periodo di osservazione.
I risultati di questo lavoro sono fondamentali per comprendere l’evoluzione delle terapia del tumore polmonare nelle ultime due decadi. Il rapido declino della mortalità dopo il 2013 è dovuto all’introduzione delle targeted therapies per i pazienti EGFR/ALK-positivi e all’impiego degli immune checkpoint inibitori. Considerando l’incidenza, il decremento è stato più rapido nel SCLC rispetto al NSCLC. Questo dato è probabilmente da ricondurre alla riduzione dell’abitudine al fumo a partire dal 1960, soprattutto negli uomini.
 

In Europa
 

PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids

Sep 4, 2020 – A review by EMA’s safety committee (PRAC) has confirmed that 5-mg ulipristal acetate (used for the treatment of symptoms of uterine fibroids can cause liver injury, including the need for liver transplantation. The PRAC has therefore recommended the revocation of the marketing authorisations of these medicines. The PRAC considered all the available evidence in its review , including reported cases of … (leggi tutto)

EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19

Sep 2, 2020 – EMA has started evaluating an application for the authorisation of Dexamethasone Taw for treating hospitalised adult patients with COVID-19. The application, from Taw Pharma, will be evaluated by EMA’s human medicines committee (CHMP) according to an accelerated assessment timetable. This will enable the CHMP to issue an opinion on the benefits and risks of Dexamethasone Taw within the … (leggi tutto)

The ESMO Asia Congress 2020 Will Take Place as a Wholly Virtual Meeting

Aug 28, 2020 – ESMO has taken the decision due to the uncertain evolution of the Coronavirus pandemic in the Asia-Pacific region and to avoid any risks to the health of the Faculty, delegates and staff. ESMO remains committed to maintaining the ESMO Asia Congress 2020 as the leading scientific platform in the Asia-Pacific region for the presentation of the latest oncology advances and state-of-the-art … (leggi tutto)

ESMO Issues First Recommendations on Using Next-Generation Sequencing for Advanced Cancers

Aug 25, 2020 – Recommendations on the use of next-generation sequencing (NGS) for patients with metastatic cancers are being launched today by the European Society for Medical Oncology (ESMO), the leading professional organisation for medical oncology. “These are the first recommendations from a scientific society about the use of NGS,” said Dr. Fernanda Mosele, first author of the recommendations … (leggi tutto)

ESMO Announces Winners of its Awards 2020

Aug 25, 2020 – The European Society for Medical Oncology (ESMO), the leading organisation for medical oncology, has announced the winners of the ESMO awards 2020. This year’s recipients of the four coveted 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 week … (leggi tutto)

Bevacizumab Biosimilar Approved in Europe

Aug 20, 2020 – The European Commission has granted a marketing authorization to a bevacizumab biosimilar for the treatment of patients with the same types of cancer for which the reference product is indicated in the European Union, according to Samsung Bioepis Co, Ltd. Specifically, the agent is indicated for use in metastatic colorectal cancer, metastatic breast cancer, non–small cell lung cancer advanced … (leggi tutto)

EMA Recommends Refusal of the Marketing Authorisation for Tagraxofusp

Aug 13, 2020 – The European Medicines Agency (EMA) has recommended the refusal of the marketing authorisation for tagraxofusp, a medicine intended for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). The Agency issued its opinion on 23 July 2020. The company that applied for authorisation, Stemline Therapeutics B.V, may ask for re-examination of the opinion within … (leggi tutto)

Communication@EMA – how are we doing?

Aug 10, 2020 – The European Medicines Agency (EMA) has launched its third communication perception survey. The purpose of the survey is to gather feedback from patients, consumers, healthcare professionals, academics, media, pharmaceutical industry and other regulators, on EMA’s external communication. The feedback will help EMA to identify and address potential shortcomings and to better meet … (leggi tutto)

EMA Recommends Granting a Marketing Authorisation for a biosimilar bevacizumab

Aug 6, 2020 – On 23 July 2020, 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, a biosimilar bevacizumab, intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), renal cell (RCC), epithelial … (leggi tutto)

Entrectinib Approved in Europe for NTRK+ Tumors and ROS1+ NSCLC

Aug 3, 2020 – The European Commission has approved entrectinib for the treatment of adult and pediatric patients ≥12 years of age with solid tumors that harbor an NTRK fusion, as well as for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer not previously treated with ROS1 inhibitors. The approval was based on data from the phase 2 STARTRK-2, phase 1 STARTRK-1, phase 1 … (leggi tutto)

ESMO’s Expert Consensus: Do Not Discontinue or Delay Cancer Treatment that May Impact on Overall Survival

Jul 31, 2020 – An ESMO interdisciplinary expert consensus paper on how to manage cancer patients during the COVID-19 pandemic has been published today in Annals of Oncology, encouraging medical oncologists worldwide not to discontinue or delay any type of anti-cancer treatment that may potentially impact on overall survival. The experts also urge to stop labelling all cancer patients as vulnerable to coronavirus … (leggi tutto)

ESMO Guidelines Discourage Delayed, Discontinued Treatment During the COVID-19 Pandemic

Jul 31, 2020 – Any type of anti-cancer therapy that could impact overall survival (OS) should not be discontinued or delayed, according to a European Society for Medical Oncology (ESMO) interdisciplinary expert consensus paper on how to manage patients with cancer during the coronavirus disease 2019 (COVID-19) pandemic. The guidelines, which were recently published in the Annals of Oncology, also … (leggi tutto)

Global regulatory workshop on COVID-19 real-world evidence and observational studies

Jul 31, 2020 – Vaccines surveillance and vigilance, collaboration on pregnancy studies and building international patient cohorts were the main topics discussed during the 3rd workshop on observational studies of real-world data in the context of COVID-19. The workshop, organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), was co-chaired by Health … (leggi tutto)

Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable endpoints for clinical trials

Jul 31, 2020 – International regulators have published a report today on the acceptability of various primary endpoints in the clinical trials conducted for the development of treatments for COVID-19. The report summarises the main outcomes of the second workshop on COVID-19 therapeutics and clinical trials organised under the umbrella of the International Coalition of Medicines Regulatory Authorities … (leggi tutto)

Dall’FDA
 

FDA Grants Priority Review to Pralsetinib for Metastatic RET+ Thyroid Cancers

Sep 5, 2020 – The FDA has granted pralsetinib a priority review for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion–positive thyroid cancer, according to an announcement from Genentech, the drug developer. The new drug application (NDA) was accepted for review under the FDA’s Real-Time Oncology Review pilot program, which seeks to … (leggi tutto)

FDA Approves Pralsetinib for Metastatic RET+ NSCLC

Sep 5, 2020 – The FDA has approved pralsetinib for the treatment of adult patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC) as detected by an FDA-approved test. “The FDA approval of [pralsetinib] for RET fusion–positive NSCLC is an important step toward our goal of providing an effective treatment option for every person diagnosed with lung cancer, no matter how rare or … (leggi tutto)

FDA Approval Sought for Axicabtagene Ciloleucel in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

Sep 4, 2020 – A supplemental biologics license application (BLA) has been filed with the FDA for axicabtagene ciloleucel (axi-cel) for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma (MZL) following 2 or more previous lines of systemic therapy, according to an announcement from Kite Pharma, the developer of the CAR T-cell product. The sBLA was based on … (leggi tutto)

FDA Approves Oral Azacitidine for Acute Myeloid Leukemia

Sep 1, 2020 – The FDA has approved oral azacitidine (CC-486) for the continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy who are not able to complete intensive curative therapy. “Continued treatment with [oral azacitidine] demonstrated an OS benefit in adults … (leggi tutto)

FDA Grants Priority Review to Oral Paclitaxel/Encequidar for Metastatic Breast Cancer

Sep 1, 2020 – The FDA has granted a priority review to a new drug application (NDA) for oral paclitaxel and encequidar (oral paclitaxel) for use in patients with metastatic breast cancer, according to an announcement from Athenex, Inc. The application was based on findings from a single pivotal phase 3 trial, which compared the use of encequidar and oral paclitaxel with intravenous (IV) paclitaxel monotherapy … (leggi tutto)

FDA Grants Priority Review to Melphalan Flufenamide for Triple-Class Refractory Myeloma

Aug 31, 2020 – The FDA has granted a priority review to a new drug application (NDA) for melphalan flufenamide for use in combination with dexamethasone in adult patients with multiple myeloma whose disease is refractory to at least 1 proteasome inhibitor (PI), 1 immunomodulatory agent (IMiD), and 1 anti-CD38 monoclonal antibody, according to an announcement from Oncopeptides, the drug developer … (leggi tutto)

FDA Approves FoundationOne Liquid CDx for Solid Tumors

Aug 27, 2020 – The FDA has approved the FoundationOne Liquid CDx, a liquid biopsy for all solid tumors with multiple companion diagnostic indications. The regulatory decision was based on analytical and clinical validation studies that collected over 7500 samples and 30,000 unique variants across more than 30 tumor types. When investigators analyzed the platform across these varied tumors, the test … (leggi tutto)

FDA Approves Generic Pemetrexed for Nonsquamous NSCLC

Aug 25, 2020 – The FDA has approved a generic form of pemetrexed for intravenous administration as a single-agent in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) that has not progressed following 4 cycles of first-line platinum-based chemotherapy. The injection was also approved for use as a single agent in the treatment of patients with recurrent, metastatic … (leggi tutto)

FDA Grants Priority Review to Tepotinib for METex14-Altered Metastatic NSCLC

Aug 25, 2020 – The FDA has granted a priority review designation to new drug application (NDA) for tepotinib as a treatment for patient with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a MET exon 14 (METex14) skipping mutation identified via an FDA-approved test. The NDA is based on data from the phase 2 VISION study (NCT02864992), which showed that the oral, highly selective … (leggi tutto)

FDA Approval Sought for Frontline Cabozantinib/Nivolumab Combo in Advanced RCC

Aug 24, 2020 – A supplemental new drug application has been submitted to the FDA for the combination of cabozantinib and nivolumab as a treatment for patients with advanced renal cell carcinoma (RCC), according to an announcement by Exelixis, the developer of cabozantinib. The application is based on findings from the phase 3 CheckMate-9ER trial, which is evaluating the combination versus sunitinib … (leggi tutto)

FDA Approves Daratumumab Plus Carfilzomib/Dexamethasone in Relapsed/Refractory Myeloma

Aug 20, 2020 – The FDA has approved daratumumab for use in combination with carfilzomib and dexamethasone (KdD) for the treatment of patients with relapsed/refractory multiple myeloma who have received 1 or more prior lines of therapy. “We are extremely pleased that multiple myeloma patients in the United States will now have yet another treatment option, as this is the eighth overall US FDA approval for … (leggi tutto)

FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma

Aug 20, 2020 – Today, the U.S. Food and Drug Administration is providing an update on adverse events reported to the Agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and systemic signs and symptoms referred to by patients as breast implant illness (BII), which some patients report after receiving breast implants. The FDA is also qualifying the … (leggi tutto)

FDA Grants Fast Track Status to Paxalisib for Glioblastoma

Aug 20, 2020 – The FDA has granted a fast track designation to paxalisib (formerly GDC-0084) for the treatment of patients with glioblastoma, according to an announcement from Kazia Therapeutics Limited, the developer of the drug. The indication is specifically for the treatment of patients with newly diagnosed glioblastoma with unmethylated O6-Methylguaninemethyltransferase (MGMT) promotor status … (leggi tutto)

FDA Halts Phase 1 Trial With P-PSMA-01 in mCRPC Following Patient Death

Aug 19, 2020 – The FDA has placed a clinical hold on the phase 1 P-PSMA-101-001 trial (NCT04249947) examining the autologous CAR T-cell therapy P-PSMA-01 in patients with metastatic castration-resistant prostate cancer (mCRPC), following a notification of a patient death that had been issued by Poseida Therapeutics, Inc, the developer of the product. The patient, who had previously progressed on several … (leggi tutto)

FDA Grants Durvalumab Priority Review for Fixed-Dose Use in NSCLC and Bladder Cancer

Aug 18, 2020 – The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for a new 4-week, fixed-dose regimen of durvalumab as treatment in approved indications of non–small cell lung cancer (NSCLC) and bladder cancer, according to AstraZeneca, the drug developer. If approved by the regulatory agency, the agent can be given via intravenous infusion every 4 … (leggi tutto)

FDA Grants Trilaciclib Priority Review for Small Cell Lung Cancer

Aug 17, 2020 – The FDA has granted a priority review designation to a new drug application (NDA) for trilaciclib for the treatment of patients with small cell lung cancer (SCLC) who are being treated with chemotherapy, according to an announcement from G1 Therapeutics Inc, the drug developer. The application was based on myelopreservation data from 3 randomized, double-blind, placebo-controlled clinical trials … (leggi tutto)

FDA Review Finds No Increased Risk of Prostate Cancer With Parkinson’s Disease Treatments Containing Entacapone

Aug 15, 2020 – A U.S. Food and Drug Administration (FDA) review of additional data found no increased risk of prostate cancer with the use of entacapone to treat Parkinson’s disease. The FDA conducted this review after an earlier trial – the Stalevo Reduction in Dyskinesia Evaluation-Parkinson’s Disease (STRIDE-PD) trial – suggested this possible risk. As a result, the FDA’s recommendations for using entacapone … (leggi tutto)

FDA Panel Supports Remestemcel-L for Pediatric Steroid-Refractory Acute GVHD

Aug 13, 2020 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8 to 2 in favor of approving remestemcel-L for the treatment of children with steroid-refractory acute graft-versus-host disease (SR-aGVHD). The FDA previously scheduled the hearing to discuss data supporting a biologics license application (BLA) for remestemcel-L for use in this setting. Specifically, the panel sought to discuss issues … (leggi tutto)

FDA Issues Complete Response Letter for Sodium Thiosulfate for Prevention of Cisplatin-Induced Ototoxicity in Solid Tumors

Aug 11, 2020 – The FDA has issued a complete response letter (CRL) to Fennec Pharmaceuticals regarding its new drug application (NDA) for a unique formulation of sodium thiosulfate for the prevention of cisplatin-induced ototoxicity in patients from 1 month to less than 18 years of age with localized, nonmetastatic, solid tumors. Following the completion of a pre-approval inspection of the manufacturing … (leggi tutto)

FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

Aug 7, 2020 – Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC). This is the first approval to combine two technologies – NGS and … (leggi tutto)

FDA Approval Sought for Omburtamab in Pediatric Metastatic Neuroblastoma

Aug 6, 2020 – The biologics license application (BLA) for the investigational B7-H3–targeting monoclonal antibody omburtamab for use in pediatric patients with central nervous system (CNS)/leptomeningeal metastases from neuroblastoma has been submitted to the FDA under the agency’s Rolling Review process, according to Y-mAbs Therapeutics, Inc. The submission is based on the safety and efficacy data from … (leggi tutto)

FDA Approves Belantamab Mafodotin-blmf for Relapsed/Refractory Multiple Myeloma

Aug 6, 2020 – The FDA has approved belantamab mafodotin-blmf as a treatment for patients with relapsed/refractory multiple myeloma who have received 4 prior therapies, including an immunomodulatory drug (IMiD), a proteasome inhibitor, and an anti-CD38 antibody. The approval is based on findings from the pivotal DREAMM-2 trial, which showed that belantamab mafodotin elicited an overall … (leggi tutto)

FDA Approves Pexidartinib for Tenosynovial Giant Cell Tumor

Aug 5, 2020 – On August 2, the U.S. Food and Drug Administration (FDA) granted approval to pexidartinib capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. “TGCT can cause debilitating symptoms for patients such as pain, stiffness, and limitation of … (leggi tutto)

FDA Grants SM-88 Orphan Drug Status for Pancreatic Cancer

Aug 3, 2020 – The FDA granted an orphan drug designation to the oral investigational modified proprietary tyrosine derivative SM-88 (racemetyrosine) as a treatment for patients with pancreatic cancer, according to an announcement from Tyme Technologies, Inc, the drug developer. “Receiving orphan drug designation for SM-88 is another important milestone to emerge from our innovative pipeline of cancer … (leggi tutto)

 Dall’ASCO  

Removing FDA Oversight of Laboratory Developed Test Approvals Threatens Safety of Cancer Care

Sep 4, 2020 – “The Association for Clinical Oncology (ASCO) has concerns that the U.S. Department of Health and Human Services (HHS) rescission of all guidance and informal issuances related to the Food and Drug Administration’s (FDA) current oversight of the premarket review and approval process for laboratory developed tests (LDTs) puts the safety of cancer treatments at risk. “ASCO has long … (leggi tutto)

Changes in Reoperation Rates After Publication of SSO/ASTRO Guideline on Margins for Breast-Conserving Surgery

Sep 1, 2020 – In a meta-analysis reported in JAMA Surgery, Marinovich et al found that reoperation rates after breast-conserving surgery in women with breast cancer declined after the publication of the Society of Surgical Oncology/American Society for Radiation Oncology (SSO/ASTRO) Consensus Guideline on Margins for Breast-Conserving Surgery. As stated by the investigators, “The 2014 publication of the … (leggi tutto)

USPSTF Recommendation on Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer

Aug 22, 2020 – As reported in JAMA, the U.S. Preventive Services Task Force (USPSTF) recommended risk assessment and, if indicated, genetic counseling and testing for potentially harmful BRCA1/2 mutations in women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have ancestry associated with BRCA1/2 mutations. The recommendation is an update to the USPSTF 2013 … (leggi tutto)

Implementation of RACE for Children Act Helps Address Unmet Needs of Children with Cancer

Aug 18, 2020 – “The Association for Clinical Oncology (ASCO) applauds implementation of the Research to Accelerate Cures and Equity (RACE) for Children Act. As of today, applications to the Food and Drug Administration for marketing approval of new drugs and biological products – including orphan drugs that have relevance to pediatric cancer – must include an assessment of pediatric use … (leggi tutto)

Greater Coverage, Patient Education, and Research for Telemedicine Needed During Pandemic and Beyond

Aug 14, 2020 – Flexibilities in reimbursement that have allowed the expanded use of telemedicine during the COVID-19 pandemic should continue and be made available to more providers and patients, says the leading organization representing cancer doctors. The group also calls for further research on telemedicine’s effectiveness and benefits. The American Society of Clinical Oncology (ASCO) today issued an interim … (leggi tutto)

USPSTF Recommendation on Screening for Pancreatic Cancer in Asymptomatic Adults

Aug 13, 2020 – As reported in JAMA, the U.S. Preventive Services Task Force (USPSTF), in a reaffirmation of its 2004 recommendation, has recommended against screening for pancreatic cancer in asymptomatic adults (a grade D recommendation). In developing the current recommendation, the USPSTF reviewed evidence on benefits and harms of screening, diagnostic accuracy of screening tests, and benefits and harms … (leggi tutto)

Nation’s Cancer Doctors Say Bolder, More Aggressive Steps Needed to Achieve Cancer Care Equity

Aug 12, 2020 – One of the nation’s leading cancer organizations today called for new actions to reduce disparities in cancer outcomes affecting racial and ethnic minorities, rural populations, sexual and gender minorities, people without insurance, and other disadvantaged populations. In a policy statement published in the Journal of Clinical Oncology (JCO), the American Society of Clinical Oncology (ASCO) argues that … (leggi tutto)

WHO Releases Report on the Global Tobacco Epidemic

Jul 30, 2020 – Many governments are making progress in the fight against tobacco, with 5 billion people today living in countries that have introduced smoking bans, warnings on packaging, and other effective tobacco control measures – four times more people than a decade ago. However, a new World Health Organization (WHO) report shows many countries are still not adequately implementing antitobacco policies … (leggi tutto)

Dal mondo  

Pembrolizumab Receives 2 New Approvals Across Oncology in Japan

Aug 24, 2020 – The Japan Pharmaceuticals and Medical Devices Agency has approved pembrolizumab for the treatment of patients with radically unresectable, advanced, or recurrent esophageal squamous cell carcinoma (ESCC) whose tumors are PD-L1–positive, and at an additional recommended dosage of 400 mg every 6 weeks as an intravenous infusion across all adult indications, according to an announcement … (leggi tutto)

Pillole dall’Aifa  



4 settembre 2020 – AIFA: vaccini influenzali per la stagione 2020-2021 

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4 settembre 2020 – Comunicazione EMA su ulipristal acetato 

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2 settembre 2020 – COVID-19 – Nuovi studi clinici autorizzati 

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1 settembre 2020 – Estensione di validità dei piani terapeutici AIFA in tema di contenimento e gestione dell’emergenza epidemiologica da COVID-19 

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1 settembre 2020 – Ristabilite le ordinarie modalità operative dei Registri di monitoraggio AIFA dopo la fase di sospensione per emergenza epidemiologica da COVID-19 

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25 agosto 2020 – Chiusura Managed Entry Agreements (MEA) Registro Alectinib (Roche) 

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21 agosto 2020 – Modalità di inserimento nella piattaforma dei Registri AIFA di confezioni importate dall’estero a fronte di stati di carenza 

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18 agosto 2020 – Chiusura Registri di monitoraggio eltrombopag (Novartis) (SAA e ITP) 

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14 agosto 2020 – Attivazione web e pubblicazione schede di monitoraggio – Registro Venetoclax secondo Legge 648/96 

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7 agosto 2020 – Report monitoraggio biosimilari 

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4 agosto 2020 – Rapporto Nazionale OsMed 2019 sull’uso dei farmaci in Italia 

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31 luglio 2020 – Centro di coordinamento nazionale dei comitati etici: modifiche al Contratto per la conduzione della sperimentazione clinica sui medicinali 

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Avviso a tutti i soci
A causa della nota emergenza coronavirus e delle relative disposizioni, si suggerisce di verificare la conferma dei singoli eventi direttamente con gli organizzatori