Oggi in Oncologia
Anastrozole Dose Escalation for Optimal Estrogen Suppression in Postmenopausal Early-Stage Breast Cancer: A Prospective Trial
Purpose: We previously reported that postmenopausal women with estrogen receptor-α-positive breast cancer receiving adjuvant anastrozole 1 mg/day (ANA1) with estrone (E1) ≥1.3 pg/mL and estradiol (E2) ≥0.5 pg/mL [inadequate estrogen suppression (IES)] had a threefold increased risk of a breast cancer event. The objective of this study was to determine if increasing … (leggi tutto)
Haddad et al. avevano già dimostrato che esiste una sostanziale variabilità interindividuale nel metabolismo dell’anastrozolo e nei suoi effetti farmacodinamici sui livelli di estrone (E1) e di estradiolo (E2) riscontrando un aumento statisticamente significativo di tre volte del rischio di una ricaduta di malattia, in pazienti con tumore mammario in fase precoce che assumevano anastrozolo con livelli plasmatici di E1 ≥1,3 pg/mL e E2 ≥0,5 pg/mL; tale associazione invece non si era riscontrata per exemestane o letrozolo (1). Pertanto, E1 e E2 rappresentano biomarkers di efficacia dell’anastrozolo.
In questo studio (2) gli stessi autori hanno esplorato l’efficacia dell’aumento del dosaggio di anastrozolo in quelle donne in postmenopausa con carcinoma mammario positivo per i recettori degli estrogeni alfa, che hanno mostrato un’inadeguata soppressione degli estrogeni (ISE) al dosaggio standard di 1 mg/die.
Lo studio ha mirato a determinare se aumentando la dose di anastrozolo a 10 mg/die (ANA10) si potesse ottenere un’adeguata soppressione degli estrogeni (ASE), con E1 <1,3 pg/mL e/o E2 <0,5 pg/mL, in pazienti precedentemente identificate con IES con il regime standard di 1 mg/die (ANA1).
Sono state identificate 156 pazienti di cui 132 (84.6%) aderenti al trattamento ANA1. Tra queste, 40 pazienti (30.3%) hanno mostrato una ISE. Lo studio ha previsto valutazioni pre- e post-trattamento dei livelli di E1 ed E2 dopo 8-10 settimane di ANA1, seguite da modifica del dosaggio ad ANA10 per quelle pazienti con ISE. Dopo altre 8-10 settimane di trattamento, indipendentemente dai livelli di E1 ed E2 post-ANA10, le pazienti con ISE sono state indirizzate a 8-10 settimane di letrozolo, somministrato al dosaggio standard di 2.5 mg/die (la sequenza tra ANA10 e letrozolo è stata scelta perché ANA10 non ancora approvato da FDA).
Gli autori hanno utilizzato un disegno prospettico, consentendo così di valutare in tempo reale l’efficacia e la sicurezza del trattamento.
I risultati hanno indicato che il 76% delle pazienti che passate al trattamento con ANA10 hanno raggiunto adeguati livelli estrogenici, evidenziando un miglioramento significativo nella soppressione degli estrogeni. Questo risultato è fondamentale, perché suggerisce che l’aumento della dose può essere una strategia valida per gestire le pazienti che non rispondono adeguatamente al dosaggio standard. Inoltre, lo studio ha mantenuto una chiara attenzione all’aderenza, con il 78% delle pazienti nella coorte ANA10 che hanno mantenuto il dosaggio, il che è risultato essenziale per la validità dei risultati.
Sebbene tutti e tre gli inibitori dell’aromatasi (AI) di terza generazione (anastrozolo, letrozolo ed exemestane) siano efficaci, le risposte individuali possono variare in modo significativo. Questo studio si aggiunge al crescente numero di evidenze che suggeriscono come approcci terapeutici personalizzati, tra cui l’aggiustamento della dose in base ai livelli di estrogeni, possano migliorare i risultati di outcome per le pazienti con carcinoma mammario ER-positivo.
Sarà necessario convalidare questi risultati con studi prospettici a più alta casistica, esplorare i benefici clinici a lungo termine del passaggio a dosi più elevate di anastrozolo o di AI alternativi e, non per ultimo, considerare un più lungo follow up anche per la rilevazione di effetti collaterali a lungo termine dei dosaggi più elevati di ANA.
In conclusione, questo studio prospettico fornisce preziose indicazioni sulla gestione del carcinoma mammario positivo ER-positivo nelle donne in postmenopausa. Le prove a sostegno dell’efficacia dell’anastrozolo ad alte dosi nel raggiungere un’adeguata soppressione degli estrogeni sono convincenti e meritano ulteriori indagini. Lo studio sottolinea l’importanza delle strategie di trattamento individualizzate in oncologia, in particolare nel contesto dei tumori ormono-sensibili. I risultati potrebbero potenzialmente portare a cambiamenti nella pratica clinica, promuovendo approcci terapeutici più personalizzati che ottimizzino i risultati delle pazienti.
1. Ingle JN, Kalari KR, Buzdar AU, Robson ME, Goetz MP, Desta Z, et al. Es- trogens and their precursors in postmenopausal women with early breast cancer receiving anastrozole. Steroids 2015;99:32–8.
2. Tufia C. Haddad, Vera J. Suman, Karthik V. Giridhar, Kostandinos Sideras, Donald W. Northfelt, Brenda J. Ernst, et al. Anastrozole Dose Escalation for Optimal Estrogen Suppression in Postmenopausal Early-Stage Breast Cancer: A Prospective Trial . Clin Cancer Res. 2024;30:3147–56
In Europa
Comprehensive Genomic Profiling with Molecularly-Guided Therapy Results in Longer PFS Compared with Platinum-based Chemotherapy in Patients with CUP
Aug 26, 2024 – CUPISCO is the first randomised study of molecularly-guided therapy for newly diagnosed unfavourable subset of patients with cancer of unknown primary (CUP). The results from this phase II, prospective, randomised, open-label, active-controlled, multicentre study show that, compared with standard platinum-based chemotherapy, molecularly-guided therapy conferred a significant and clinically meaningful improvement … (leggi tutto)
EMA Recommends Extension of Therapeutic Indications for Encorafenib and Binimetinib
Aug 23, 2024 – On 25 July 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal products encorafenib (Braftovi) and binimetinib (Mektovi). The marketing authorisation holder … (leggi tutto)
Superior Prognostic Accuracy of Integrated 15-GEP/PRAME Classifier Over 15-GEP Alone in Uveal Melanoma
Aug 22, 2024 – The Collaborative Ocular Oncology Group Study No. 2 (COOG2) is the largest multicentre prospective biomarker study to date in uveal melanoma, with longer follow-up and more representative, real-world distribution of tumour size, ciliary body involvement, and AJCC tumour stage than COOG1 or The Cancer Genome Atlas and more similar to a large international database encompassing the full spectrum of uveal melanoma … (leggi tutto)
EMA Recommends Granting a Marketing Authorisation for Toripalimab
Aug 21, 2024 – On 25 July 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product toripalimab (Loqtorzi), intended for the treatment of nasopharyngeal carcinoma and oesophageal squamous cell carcinoma. The applicant for this medicinal product … (leggi tutto)
Preliminary Evidence of Efficacy of an Upfront ICI-based Therapeutic Strategy in pMMR mCRC with Supporting Findings from Translational Analyses
Aug 20, 2024 -Overall survival (OS) from the AtezoTRIBE study at around 4 years of median follow-up and updated outcomes according to tumour immune-related biomarkers, both in the intention-to-treat (ITT) population and the cohort of patients with proficient mismatch repair (pMMR) tumours indicate that first-line FOLFOXIRI plus bevacizumab and atezolizumab improves OS … (leggi tutto)
Neoadjuvant Docetaxel, Oxaliplatin, and S-1, as Part of Perioperative Chemotherapy, Prolongs Survival in Asian Patients with Locally Advanced Gastric Cancer
Aug 19, 2024 – In a long-term follow-up analysis of the randomised phase III PRODIGY study, adding neoadjuvant chemotherapy with docetaxel, oxaliplatin, and S-1 to standard D2 surgery plus adjuvant S-1 chemotherapy significantly prolonged overall survival (OS) compared with surgery followed by adjuvant S-1 in Asian patients with resectable locally advanced gastric cancer. Benefit in progression-free survival (PFS) with neoadjuvant chemotherapy previously … (leggi tutto)
EMA Recommends Granting a Marketing Authorisation for Generic Nilotinib
Aug 16, 2024 – On 27 June 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nilotinib Accord (nilotinib), intended for the treatment of chronic myelogenous leukaemia (CML). The applicant for this medicinal product is Accord Healthcare S.L.U. … (leggi tutto)
Neoadjuvant Chemotherapy with mFOLFIRINOX Followed by Chemoradiotherapy Improves Survival in Patients with Locally Advanced Rectal Cancer
Aug 14, 2024 – Previously reported findings from a multicentre, randomised, open-label, phase III, UNICANCER-PRODIGE 23 study demonstrated improved disease-free survival (DFS) and metastatic-free survival (MFS) with total neoadjuvant therapy versus standard-of-care in patients with locally advanced rectal adenocarcinoma. In a long-term follow-up analysis of this study … (leggi tutto)
Virchow: The Largest Foundation Model for Computational Pathology To Date
Aug 13, 2024 – Trained on 1.5 million whole-slide images from 100,000 patients from the Memorial Sloan Kettering Cancer Center (MSKCC), a pathology foundation model Virchow, named in honour of Dr. Rudolf Virchow, is shown to enable pan-cancer detection and improve performance of specialised models in detection of rare cancers. The results provide evidence that large-scale foundation models can be the basis for robust results … (leggi tutto)
Adding Blinatumomab to Consolidation Chemotherapy Improves OS in Adult Patients in MRD-negative Remission from BCP-ALL
Aug 12, 2024 – In a randomised phase III, E1910 study, conducted through the National Clinical Trials Network of the US National Cancer Institute (NCI), the investigators from the Eastern Cooperative Oncology Group–American College of Radiology Imaging Network (ECOG-ACRIN) showed an overall survival (OS) benefit with adding blinatumomab to consolidation chemotherapy in patients with BCR::ABL1-negative disease … (leggi tutto)
EMA Recommends Granting a Marketing Authorisation for Generic Enzalutamide
Aug 09, 2024 – On 27 June 2024, 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 Enzalutamide Viatris (enzalutamide), intended for the treatment of prostate cancer. The applicant for this medicinal product is Viatris Limited. … (leggi tutto)
Efficacy and Safety of Adding Antiangiogenesis Therapy to First-Line Immunochemotherapy in Patients with Extensive-Stage SCLC
Aug 08, 2024 – Based on the final progression-free survival (PFS) analysis and interim overall survival (OS) analysis, the phase III ETER701 study demonstrated that benmelstobart and anlotinib plus etoposide/carboplatin provide significant improvements in survival compared with etoposide/carboplatin chemotherapy alone among patients with extensive-stage small-cell lung cancer (ES-SCLC) … (leggi tutto)
ViPOR Regimen Associated with Durable Remissions in Patients with Specific Molecular DLBCL Subtypes
Aug 07, 2024 – In a phase Ib/II study conducted in patients with relpased or refractory diffuse large B-cell lymphoma (DLBCL), use of a regimen consisting of venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR) with simultaneous targeting of multiple pathways was shown as potentially curative in specific molecular subtypes. To optimise multiagent drug synergy, the study team designed … (leggi tutto)
FDA Approves Blinatumomab as Consolidation for CD19-positive Philadelphia Chromosome-negative B-Cell Precursor Acute Lymphoblastic Leukaemia
Aug 06, 2024 – On 14 June 2024, the US Food and Drug Administration (FDA) approved blinatumomab (Blincyto, Amgen Inc.) for adult and paediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukaemia (Ph-negative BCP ALL) in the consolidation phase of multiphase chemotherapy … (leggi tutto)
Telisotuzumab Vedotin Associated with Durable Responses in c-Met Protein–Overexpressing Non-Squamous EGFR-wild-type NSCLC and Enriched ORRs in Patients with High c-Met Expression
Aug 05, 2024 – A phase II LUMINOSITY study aimed to determine which patients with c-Met protein–overexpressing non-small cell lung cancer (NSCLC) would most benefit from treatment with telisotuzumab vedotin. The non-squamous EGFR-wild-type NSCLC cohort met criteria for expansion, while the squamous and non-squamous EGFR-mutated cohorts met protocol-specified criteria for futility. The highest overall response … (leggi tutto)
EMA Recommends Extension of Therapeutic Indications for Durvalumab to Patients with Primary Advanced or Recurrent Endometrial Cancer
Aug 02, 2024 – On 27 June 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product durvalumab (Imfinzi). The marketing authorisation holder for this medicinal product is AstraZeneca AB. The CHMP adopted a new indication as follows: … (leggi tutto)
New pilot programme to support orphan medical devices
Aug 01, 2024 – EMA has launched a pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union (EU). The pilot programme offers free advice from the medical device expert panels to selected manufacturers and notified bodies on the orphan device status and the data needed for their … (leggi tutto)
FDA Grants Accelerated Approval to Epcoritamab-bysp for Relapsed or Refractory Follicular Lymphoma
Jul 31, 2024 – On 26 June 2024, the Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Efficacy and safety were evaluated in EPCORE NHL-1 … (leggi tutto)
Dall’FDA
FDA Grants Fast Track Designation to BGB-16673 in Previously Treated CLL/SLL
Aug 26, 2024 – The FDA has granted fast track designation to BGB-16673 for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received 2 or more prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.1 The designation is based on data from the phase 1/2 CaDAnCe-101 trial (BGB-16673 ... (leggi tutto)
INV724 Earns FDA Rare Pediatric Disease, Orphan Drug Designations for Neuroblastoma
Aug 23, 2024 – The FDA has awarded rare pediatric disease designation and orphan drug designation to INV724 for the treatment of patients with neuroblastoma.1 Developed in collaboration with Carbone Cancer Center of the University of Wisconsin, INV724 is a novel antibody designed to target GD2 and B7-H3 tumor antigens, and the agent is intended to mitigate ... (leggi tutto)
FDA Grants Fast Track Designation to Neoadjuvant APG-157 for Head and Neck Cancer
Aug 23, 2024 – The FDA has granted fast track designation to APG-157 for the neoadjuvant treatment of head and neck cancer.1 APG-157 is a first-in-class botanical drug developed through the FDA’s Botanical Drug Development, and is designed to deliver its active components to oromucosal tissues near the tumor target in patients with head and neck cancer.2 The dual mechanism of the agents is intended to induce selective apoptosis of cancer … (leggi tutto)
FDA Roundup: August 23, 2024
Aug 23, 2024 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a Small Entity Compliance Guide (SECG) to assist small entities, including mammography facilities, in complying with the FDA’s March 2023 final rule (“2023 MQSA Rule”) amending regulations issued under the Mammography Quality Standards Act of 1992 (MQSA) and the ... (leggi tutto)
FDA Accepts sBLA for First-Line Nivolumab Plus Ipilimumab in Unresectable HCC
Aug 21, 2024 – The FDA has accepted a supplemental biologics license application (sBLA) seeking the approval of the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for the first-line treatment of adult patients with unresectable hepatocellular carcinoma (HCC).1 The sBLA is supported by data from the phase 3 CheckMate 9DW trial (NCT04039607) ... (leggi tutto)
FDA Grants BTD to GSK5764227 for Extensive-Stage Small Cell Lung Cancer
Aug 20, 2024 – The FDA has awarded breakthrough therapy designation to the B7-H3–targeted antibody-drug conjugate (ADC), GSK5764227 (HS-20093), for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) that has progressed on or following platinum-based chemotherapy.1 The designation is supported by findings from the phase 1 ARTEMIS-001 study (NCT05276609) … (leggi tutto)
FDA Approves First-Line Amivantamab Plus Lazertinib for EGFR+ Advanced NSCLC
Aug 20, 2024 – The FDA has approved amivantamab-vmjw (Rybrevant) in combination with lazertinib (Lazcluze) for the first-line treatment of adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.1 The regulatory decision was supported by data from the phase 3 MARIPOSA trial (NCT04487080) which showed that amivantamab ... (leggi tutto)
FDA Roundup: August 20, 2024
Aug 20, 2024 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA approved Lazcluze (lazertinib) in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon … (leggi tutto)
FDA Awards Orphan Drug Designation to PT217 for Neuroendocrine Carcinoma
Aug 19, 2024 – The FDA has granted orphan drug designation to PT217 for use as a potential therapeutic option in patients with neuroendocrine carcinoma, according to an announcement by drug developer, Phanes Therapeutics, Inc.1 The safety, tolerability, and preliminary efficacy of the first-in-class, bispecific antibody designed to target DLL3 and ... (leggi tutto)
FDA Lifts Partial Clinical Hold on Phase 1 Trial of YL202 in Advanced NSCLC and Breast Cancer
Aug 19, 2024 – The FDA has lifted the partial clinical hold placed on the phase 1 YL202-INT-101-01 trial (NCT05653752) evaluating YL202 (BNT326) for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR mutations or hormone receptor (HR)–positive, HER2-negative breast cancer.1 … (leggi tutto)
FDA Grants Priority Review to Vimseltinib in Tenosynovial Giant Cell Tumor
Aug 16, 2024 – The FDA has accepted and granted priority review to a new drug application (NDA) for vimseltinib (DCC-3014), a colony-stimulating factor 1 receptor (CSF1R)-directed therapy, for the treatment of patients with tenosynovial giant cell tumor (TGCT), according to a press release from Ono Pharmaceutical, which added that the regulatory body assigned a Prescription Drug User Fee Act goal date of February 17, 2025.1 ... (leggi tutto)
FDA Roundup: August 16, 2024
Aug 16, 2024 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued notice of a Warning Letter sent to AUSTROFOOD S.A.S. (Austrofood), the manufacturer of the apple cinnamon fruit puree pouches that were recalled last year and that were found to contain elevated levels of lead and chromium … (leggi tutto)
FDA Approves Perioperative Durvalumab Plus Chemotherapy in Resectable NSCLC
Aug 15, 2024 – The FDA has approved durvalumab (Imfinzi) in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery, for adult patients with resectable (tumors ≥4 cm and/or node positive) non–small cell lung cancer and no known EGFR mutations or ALK rearrangements.1 ... (leggi tutto)
FDA Approval Insights: Durvalumab/Chemotherapy in dMMR Advanced Endometrial Cancer
Aug 15, 2024 – OncLive On Air is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions ... (leggi tutto)
FDA Grants Priority Review to Durvalumab for LS-SCLC After Concurrent Chemoradiotherapy
Aug 15, 2024 – The FDA has granted priority review to the supplemental biologics license application (sBLA) seeking the approval of durvalumab (Imfinzi) for the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based concurrent chemoradiotherapy.1 Additionally, the regulatory agency awarded breakthrough therapy designation to durvalumab for this indication. … (leggi tutto)
FDA Approves Axatilimab for Chronic Graft-vs-Host Disease
Aug 14, 2024 – The FDA approved axatilimab-csfr (Niktimvo) for the treatment of adult and pediatric patients weighing at least 40 kg with chronic graft-vs-host disease (cGVHD) who have progressed on at least 2 prior lines of systemic therapy.1 The regulatory decision was supported by findings from the randomized, open-label, multicenter, phase 2 AGAVE-201 trial (NCT04710576), which evaluated 3 dose ... (leggi tutto)
Deltacel Plus Radiation Wins FDA Fast Track Designation for Pretreated Metastatic NSCLC
Aug 14, 2024 – The FDA has granted fast track designation to Deltacel (KB-GDT-01) in combination with low-dose radiation therapy as a potential therapeutic option for patients with metastatic non–small cell lung cancer (NSCLC) who have progressed on 2 or more prior lines of standard-of-care therapy, including platinum-based chemotherapy, immune checkpoint inhibitors, and targeted therapy.1 … (leggi tutto)
FDA Grants Fast Track Status to AC699 for ER+/HER2–, ESR1-Mutated Breast Cancer
Aug 14, 2024 – The FDA has awarded fast track designation to the investigation of AC699 as a potential therapeutic option for patients with estrogen receptor (ER)–positive, HER2-negative, ESR1-mutated, advanced or metastatic breast cancer that progressed on or following 1 more lines of endocrine-based therapy.1 The orally bioavailable, chimeric ERα degrader is designed to bring an ER ligand to cereblon E3 ligase and elicit subsequent ubiquitination and ER degradation.2 ... (leggi tutto)
FDA Approval Sought for UGN-102 in Low-Grade, Intermediate-Risk NMIBC
Aug 14, 2024 – A new drug application (NDA) has been submitted to the FDA seeking the approval of mitomycin for intravesical solution (UGN-102) for the treatment of patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer (NMIBC).1 UroGen, the developer of UGN-102, expects a decision regarding potential approval from the FDA in early 2025, provided the NDA is accepted for filing by the regulatory agency and is granted priority review.... (leggi tutto)
FDA Roundup: August 13, 2024
Aug 13, 2024 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted two warning letters issued to BullyKamp Products LLC and Top Dog Pet Store LLC dba The Bulldog Cartel, for marketing unapproved animal drugs intended for dogs, in violation of federal law. Because the unapproved animal drugs have not been submitted to the FDA for review … (leggi tutto)
FDA Roundup: August 9, 2024
Aug 09, 2024 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA invites the public to register for the public meeting on the Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food, which will be held on September 25, 2024, from 12:30-4:30 p.m. ET ... (leggi tutto)
FDA Approves Vorasidenib for IDH1/2+ Grade 2 Astrocytoma or Oligodendroglioma
Aug 06, 2024 – The FDA has approved vorasidenib (Voranigo) for the treatment of adult and pediatric patients 12 years of age and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, sub-total resection, or gross total resection.1 The regulatory decision was supported by data from the phase 3 INDIGO trial (NCT04164901), which showed that at a median follow-up of 14.0 months ... (leggi tutto)
FDA Accepts sNDA for Cabozantinib in Advanced Pancreatic and Extra-Pancreatic NETs
Aug 06, 2024 – The FDA has accepted a supplemental biologics license applications (sNDA) seeking the approval of cabozantinib (Cabometyx) for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic, well- or moderately differentiated pancreatic neuroendocrine tumors (NETs) and the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic, well- or moderately differentiated extra-pancreatic NETs.1 … (leggi tutto)
FDA Roundup: August 6, 2024
Aug 02, 2024 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA issued a Safety Alert advising restaurants and retailers not to serve or sell, and consumers not to eat certain oysters from Lewis Bay, Massachusetts, due to potential contamination with Campylobacter jejuni ... (leggi tutto)
FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma
Aug 02, 2024 – The U.S. Food and Drug Administration approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA antigen(s) A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA authorized companion diagnostic devices … (leggi tutto)
FDA Roundup: August 2, 2024
Aug 02, 2024 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “Advancing Clinical Trial Participation for the LGBTQIA+ Community,” by Christine Lee, Acting Associate Commissioner for Minority Health, Office of Minority Health and Health Equity. Representatives of the FDA were fortunate to attend a community discussion on advancing clinical ... (leggi tutto)
PGDx Elio Plasma Focus Dx Receives FDA De Novo Marketing Authorization for Pan–Solid Tumor Liquid Biopsy
Aug 02, 2024 – The FDA has granted de novo marketing authorization to the PGDx elio plasma focus Dx pan–solid tumor liquid biopsy test for tumor mutation profiling via simple blood draw.1 PGDx elio plasma focus DX is the first and only kitted, pan–solid tumor liquid biopsy test. The qualitative next-generation sequencing–based in vitro diagnostic uses a targeted high throughput hybridization-based approach to capture single-nucleotide variants (SNVs) ... (leggi tutto)
FDA Grants Accelerated Approval to Afami-Cel for Advanced Synovial Sarcoma
Aug 02, 2024 – The FDA has granted accelerated approval to afamitresgene autoleucel (afami-cel; Tecelra) for the treatment of adult patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy; are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive; and whose tumors express MAGE-A4, as determined by FDA-approved or -cleared companion diagnostic devices … (leggi tutto)
FDA Awards Orphan Drug Designation to Avutometinib Plus Defactinib in Pancreatic Cancer
Aug 02, 2024 – The FDA granted an orphan drug designation to the combination of avutometinib and defactinib for use as a potential therapeutic option in patients with pancreatic cancer.1 The doublet paired with standard-of-care (SOC) gemcitabine and nab-paclitaxel (Abraxane) is under investigation as a first-line treatment in the phase 1b/2 RAMP 205 study (NCT05669482).2 Data reported at the 2024 ... (leggi tutto)
FDA Approves Expanded Indication for Dostarlimab Plus Chemo in Primary Advanced or Recurrent Endometrial Cancer
Aug 01, 2024 – The FDA has approved dostarlimab-gxly (Jemperli) in combination with carboplatin and paclitaxel, followed by single-agent dostarlimab, for the treatment of adult patients with primary advanced or recurrent endometrial cancer.1,2 Previously in July 2023, the regulatory agency approved the combination, followed by dostarlimab monotherapy, for use in adult patients with primary ... (leggi tutto)
IMM-1-104 Earns FDA Fast Track Designation for First-Line PDAC
Aug 01, 2024 – The FDA has granted fast track designation to IMM-1-104 as a potential therapeutic option in the first-line treatment of patients with pancreatic ductal adenocarcinoma (PDAC).1 The oral agent designed to promote universal RAS activity via deep cyclic inhibition of the MAPK pathway previously received fast track designation in February 2024 for patients with PDAC whose disease progressed after 1 line of therapy.2 … (leggi tutto)
FDA Grants Rare Pediatric Drug Designation to VCN-01 for Retinoblastoma
Jul 31, 2024 – The FDA has granted rare pediatric drug designation to VCN-01 for the treatment of patients with retinoblastoma, following its prior receipt of orphan drug designation from the regulatory agency in February 2022.1,2 “The FDA’s decision to grant rare pediatric drug designation to VCN-01 highlights the urgent need for new treatment options for pediatric patients with retinoblastoma,” ... (leggi tutto)
Dall’ASCO
Podcast: Key Takeaways From 2024 ASCO Breakthrough
Aug 22, 2024 – Dr. Lillian Siu: Hello and welcome to the ASCO Daily News Podcast. I’m Dr. Lillian Siu, a medical oncologist and director of the Phase 1 Trials Program at the Princess Margaret Cancer Center in Toronto, Canada, and a professor of medicine at the University of Toronto. On today’s episode, we’ll be discussing key takeaways from the 2024 ASCO … (leggi tutto)
A New Milestone for Medicare: How the Inflation Reduction Act Cuts Out-of-Pocket Costs
Aug 21, 2024 – The Inflation Reduction Act is helping lower prescription spending for patients insured by Medicare, representing major progress in improving access to cancer care and mitigating financial toxicity of treatment. The law establishes a cap on out-of-pocket spending for Medicare beneficiaries and enables Medicare drug price negotiations for the first time in history. … (leggi tutto)
The Gut Microbiome Plays a Key Role in Immunity. Can Ingesting Probiotic Foods Improve Patient Health?
Aug 21, 2024 – Dysbiosis of the gut microbiome has broad ramifications for human health, including cancer outcomes. Diet is a key determinant of gut microbiome structure and output, with fermented probiotic-containing foods demonstrating positive immunologic, digestive, and metabolic bodily effects. Promising research indicates that consuming probiotic foods may enhance cancer immunotherapy response, but further testing is needed. … (leggi tutto)
IMpassion132: Learning From Immunotherapy’s Failures in Early Relapsing Triple-Negative Breast Cancer
Aug 15, 2024 – Triple-negative breast cancer (TNBC) carries nearly 3 times the risk of distant recurrence within 5 years of diagnosis compared with non-TNBC. The subset that relapses within 12 months after curative treatment is defined as early relapsing TNBC and has a very poor prognosis. IMpassion132, a phase 3 trial of chemotherapy plus immune checkpoint inhibition (ICI) specifically for early relapsing … (leggi tutto)
The Majority of Patients With Foregut Cancers Do Not Receive Guideline-Concordant Care. Solutions Must Extend Beyond the Clinic
Aug 14, 2024 – Despite advances in therapies for foregut cancers, disparities in outcomes persist, with up to 70% of patients failing to receive guideline-concordant treatment. Understanding the root causes of cancer disparities in foregut cancer care is the first step in developing holistic, multipronged solutions to improve the equitable distribution of high-quality care to all patients … (leggi tutto)
Planning Your #ASCOQLTY24 Meeting Experience
Aug 14, 2024 – Join us September 27-28 at the 2024 ASCO Quality Care Symposium, the premier meeting addressing quality, safety, and efficiency of care delivery. Leaders of the quality care community will come together in San Francisco to promote innovation, collaboration, and cooperation in cancer-focused quality improvement and measurement and health services research … (leggi tutto)
Managing Myeloid Neoplasms With Low-Risk Phenotype and High-Risk Mutations Is a New Frontier
Aug 14, 2024 – Traditionally, management of myeloid malignancies was driven by patient symptom burden, transfusion needs from cytopenias, and perceived risk of disease progression. Clinicians now have improved understanding of how molecular alterations impact disease risk, and next-generation sequencing may detect high-risk mutations in patients who would not historically warrant treatment … (leggi tutto)
Risk Communication Intervention Fails to Improve Smoking Cessation Rates in Patients With Cancer
Aug 12, 2024 – In a recent randomized trial, a risk communication–based strategy was ineffective at helping patients with cancer quit smoking. Changes to patients’ state of readiness to quit smoking between 1 and 6 months was similar in both groups: 16.4% of patients in the intervention group had an increased state of readiness at 6 months, compared with 14.2% in the control group (P = .37) … (leggi tutto)
Enfortumab Vedotin Plus Pembrolizumab Offer Improved Survival Without Detriment to Quality of Life
Aug 12, 2024 – Enfortumab vedotin and pembrolizumab (EV+P) significantly improved survival outcomes compared with chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer. According to analysis from the phase 3 EV-302 study, there was no significant drop in patient-reported outcomes (PROs). The study results also favored EV+P in terms of social functioning, quality-of-life (QoL) scores … (leggi tutto)
Radiation Therapy Offers Similar Outcomes, Less Toxicity to Concurrent Chemoradiotherapy for Low-Risk Nasopharyngeal Carcinoma
Aug 12, 2024 – Results of a recent phase 3 trial found that treatment with intensity-modulated radiation therapy (IMRT) alone provides similar 5-year survival and disease control outcomes to concurrent chemoradiotherapy (CCRT) in patients with low-risk nasopharyngeal carcinoma (NPC). Omitting chemotherapy reduced toxicity and lowered the incidence of hearing impairment. … (leggi tutto)
Pillole dall’AIFA
23 agosto 2024 – Aggiornamento “Diario di bordo sulla Trasparenza”
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22 agosto 2024 – Modifiche monitoraggio JAKAVI (MF) – Registro semplificato
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22 agosto 2024 – Chiusura Registro di monitoraggio HEMLIBRA
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22 agosto 2024 – Chiusura Registro di monitoraggio JAKAVI (PV)
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21 agosto 2024 – Nota Informativa Importante su Glatiramer acetato
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21 agosto 2024 – Linea Guida per la classificazione e conduzione degli studi osservazionali sui farmaci
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21 agosto 2024 – Linea Guida in materia di semplificazione regolatoria ed elementi di decentralizzazione ai fini della conduzione di sperimentazioni cliniche dei medicinali
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21 agosto 2024 – Notifica dei provvedimenti – Ufficio Ispezioni e Autorizzazioni GMP Medicinali
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21 agosto 2024 – Chiusura Registro di monitoraggio QARZIBA
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19 agosto 2024 – Nota Informativa Importante sulla carenza del medicinale NovoSeven (eptacog alfa)
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16 agosto 2024 – Aggiornamento “Diario di bordo sulla Trasparenza”
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13 agosto 2024 – Attivazione web e pubblicazione scheda di monitoraggio – PT web JARDIANCE (MRC)
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13 agosto 2024 – Modifica PT web based Jardiance (ICCS)
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13 agosto 2024 – Chiusura Managed Entry Agreements (MEA) Registro CYRAMZA
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13 agosto 2024 – Chiusura Registro di monitoraggio CYRAMZA
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09 agosto 2024 – Aggiornamento “Diario di bordo sulla Trasparenza”
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09 agosto 2024 – Aggiornamento Registro PHESGO (EBC)
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05 agosto 2024 – Attivazione web e pubblicazione schede di monitoraggio – Registri NEXPOVIO (MM)
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05 agosto 2024 – Modifica Registro TECARTUS (MCL)
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05 agosto 2024 – Manutenzione straordinaria dei servizi online AIFA
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02 agosto 2024 – Aggiornamento “Diario di bordo sulla Trasparenza”
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02 agosto 2024 – Esito avviso per il conferimento del posto di funzione dirigenziale di livello non generale di direzione dell’Ufficio Registri di Monitoraggio
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02 agosto 2024 – Sunset Clause – Warning di prossima decadenza del 31 luglio 2024
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02 agosto 2024 – EMA avvia la revisione di Oxbryta, medicinale indicato per l’anemia falciforme
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02 agosto 2024 – Ripiano della spesa farmaceutica per acquisti diretti per l’anno 2023 – Avvio del procedimento – Esposizione dati
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02 agosto 2024 – Spesa farmaceutica per acquisti diretti
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01 agosto 2024 – Modifica Registro ZEJULA
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01 agosto 2024 – AIFA aggiorna le Liste di Trasparenza
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01 agosto 2024 – Simposio GCP del 6 dicembre 2024: aperte le iscrizioni
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01 agosto 2024 – Requisiti aggiuntivi per la creazione di tutti gli eCTD da sottomettere sul Portale CESP
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31 luglio 2024 – Nota Informativa Importante su Ocaliva (acido obeticolico)
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