Bristol Myers Squibb looks on track to overtake Amgen as the KRAS leader in lung cancer after following up its rival’s FDA setback with a positive confirmatory trial readout.
Verastem Oncology Granted Fast Track Designation for Combination of Avutometinib and Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC)
FDA declines to grant Amgen’s Lumakras full approval in lung cancer
Amgen Chief Medical Officer Paul Burton, M.D., is sticking with the high dose of Lumakras for now after FDA advisers knocked down confirmatory results earlier this year, as a dose optimization study continues.
BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM) (the “Company”), a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced today the initial safety, pharmacokinetics and recommended Phase 2 dose (RP2D) in the RAMP 203 trial evaluating the safety, tolerability and efficacy of avutometinib in combination with sotorasib in patients with KRAS G12C-mutant non-small cell lung cancer (NSCLC). The results will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics October 11-15, 2023 in Boston, Massachusetts.
Oct 5 (Reuters) - Advisers to the U.S. Food and Drug Administration on Thursday found that data from a late-stage trial of Amgen's (AMGN.O) Lumakras could not be relied on, raising questions about the agency's upcoming decision on whether to grant traditional approval of the drug for a type of advanced lung cancer.
Oct 3 (Reuters) - The U.S. Food and Drug Administration staff reviewers said on Tuesday Amgen's (AMGN.O) late-stage study might not be sufficient to confirm the effectiveness for its lung cancer drug, as the firm pursues a traditional nod for the treatment.
As an FDA advisory committee gears up to discuss the data supporting Amgen’s Lumakras, a pre-meeting briefing document from the agency suggests the KRAS inhibitor might have a tough road ahead.
THOUSAND OAKS, Calif., Sept. 10, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced exciting data from a study arm of the CodeBreaK 101 clinical trial, a Phase 1b study evaluating LUMAKRAS® (sotorasib) with carboplatin and pemetrexed in adult patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). These results were featured in an oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) in Singapore on Sunday, September 10.
Despite the FDA approvals of adagrasib (Krazati) and sotorasib (Lumakras), developing new combination regimens remains an important area of interest for the treatment of patients with KRAS G12C–mutant advanced non–small cell lung cancer (NSCLC), according to Lyudmila A. Bazhenova, MD.