Amgen Provides Regulatory Update on the Status of Lumakras® (Sotorasib)

This review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer. The FDA also issued a new postmarketing requirement for an additional confirmatory study to support full approval that will be completed no later than February 2028.