Pierre Fabre Laboratories announced today that the European Medicines Agency (EMA) validated the submission for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for the treatment of adult patients with BRAFV600-mutant advanced non-small cell lung cancer (NSCLC), who are either treatment naïve or have received prior therapy.
U.S. FDA Approves Pfizer’s BRAFTOVI® + MEKTOVI® for BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer
Novel combinations are in development for the treatment of patients with BRAF V600-muated non–small cell lung cancer (NSCLC), and although resistance remains a challenge and questions regarding how to best sequence targeted agents in the treatment paradigm, encorafenib (Braftovi) plus binimetinib (Mektovi) has shown promising efficacy in this patient population, according to Corey J. Langer, MD.
Enforcement Report - Week of April 19, 2023
FDA Confirms Paragraph IV Patent Litigation for Mektovi (Binimetinib)
Amber Specialty Pharmacy announces today that they will begin dispensing 13 Pfizer oncology products. The pharmacy’s comprehensive service model will support patients, caregivers, and oncology specialists throughout the country. Their Oncology Center of Excellence provides an enhanced level of care throughout a patient’s treatment journey.
BOULDER, Colo., June 02, 2022 (GLOBE NEWSWIRE) -- OnKure, Inc., a clinical-stage biopharmaceutical company discovering and developing the next generation of oncology precision medicines, today...
EORTC and Pierre Fabre launch phase 3 trial for melanoma
Pierre Fabre and the European Organisation for Research and Treatment of Cancer (EORTC) today announced the screening of the first patient with a resected stage II BRAF-mutant melanoma for the phase III study COLUMBUS-AD (NCT05270044; EORTC-2139-MG).
SOUTH SAN FRANCISCO, Calif., March 23, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced dose expansion of the ongoing Phase 1/2 study (ClinicalTrials.gov Identifier: NCT03947385) evaluating the combination of IDE196 and binimetinib in metastatic uveal melanoma (MUM). IDEAYA is the sponsor of this combination study, which is being conducted pursuant to a clinical trial collaboration and drug supply agreement with Pfizer. IDE196 is IDEAYA's clinical stage protein kinase C, or PKC, inhibitor and binimetinib is a MEK inhibitor to which Pfizer has exclusive rights in the U.S. and Canada.