FDA gives Amgen second chance at confirmatory study after AADecember 27, 2023 - Amgen's Lumakras was granted accelerated approval in May 2021 to treat second line KRAS G12C-mutated NSCLC. The company was asked by the FDA to launch a confirmatory trial and a dose optimization study to gain a full approval.
Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California pharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod.
Despite the negative vote, the agency was not expected to remove Lumakras from the market, but instead request another confirmatory trial. Amgen now says that’s exactly what the FDA has done, with the request to flip the accelerated approval into a full approval rejected with a complete response letter.
Accelerated approval is granted to therapies that treat serious conditions and fill an unmet medical need based on a surrogate endpoint that predicts clinical benefit. The FDA requires companies to complete a confirmatory trial to prove clinical benefit to gain the full approval.
https://www.fiercepharma.com/pharma/amgens-request-full-approval-lumakras-lung-cancer-denied-fda