The Committee discusses Amgen’s supplemental New Drug Application (sNDA) 214665/S-005, for LUMAKRAS (sotorasib) tablets for proposed treatment of adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer. This supplement proposes to convert the NDA to full approval based on the confirmatory study, CodeBreaK 200. The virtual meeting will be held on October 5 at 9:30 am. Webcast Link
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