Full Approval For Amgen's Flagship Cancer Drug Lumakras Pushed For Around Four Years
Portfolio Pulse from Vandana Singh
The FDA has issued a Complete Response Letter to Amgen Inc (NASDAQ:AMGN) for full approval of Lumakras, a drug for KRAS G12C-mutated non-small cell lung cancer (NSCLC). Doubts were raised by FDA advisers in October about the primary goal of the late-stage study. The FDA requires an additional study to be completed by February 2028 for full approval. Lumakras received accelerated approval in May 2021 and has been used by over 15,000 patients globally. Amgen's shares dropped slightly by 0.45% to $282.89.
December 26, 2023 | 3:45 pm
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Amgen faces a setback as the FDA requires an additional study for full approval of Lumakras, potentially delaying its full market potential until 2028. The drug remains available under accelerated approval.
The FDA's decision to require an additional study for full approval of Lumakras may be seen as a regulatory hurdle, potentially delaying the drug's full commercial potential and impacting investor sentiment negatively in the short term. However, the drug's continued availability under accelerated approval and the completion of a dose comparison study mitigate the impact slightly.
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