- In May 2021, Amgen announced the U.S. Food and Drug Administration (FDA) approval for LUMAKRAS (sotorasib) for treating 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. LUMAKRAS was given priority approval due to its high overall response rate (ORR) and short response time. Continued approval for this indication could be conditional on a confirmatory trial demonstrating and documenting clinical trials
