Dec. 26, 2023, Amgen announced that the U.S. FDA has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS (sotorasib).
LUMAKRAS (sotorasib) is an oral, first-in-class therapy indicawithted for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) following at least one previous systemic therapy.
Sotorasib is the first approved targeted therapy for patients with tumors with any KRAS mutation, which accounts for approximately 25% of mutations in NSCLC. The U.S. FDA granted the application for sotorasib orphan drug, fast track, priority review, and breakthrough therapy designations.