Oncologic Drugs Advisory Committee Meeting

The committee will discuss supplemental new drug application (sNDA) 214665/s-005, for LUMAKRAS (sotorasib) tablets, submitted by Amgen Inc., for the proposed treatment of adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy. This supplement proposes to convert the NDA to full approval based on the confirmatory study, CodeBreaK 200. The committee will consider the results of the CodeBreaK 200 study and discuss the benefit-risk profile of Lumakras.