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.
Merck initiates Phase 3 clinical trial of MK-1084, an investigational oral KRAS G12C inhibitor, in combination with KEYTRUDA® (pembrolizumab) for first-line treatment of certain patients with metastatic non-small cell lung cancer. KRAS mutations are one of the most frequently observed mutations in human cancers, making them a crucial target for precision oncology therapy.
MK-1084 is an investigational, oral covalent inhibitor of KRAS G12C, that is found in about 14% of people with non-small cell lung cancer. MK-1084 is currently under Phase 1 evaluation as monotherapy and as combined therapies in patients with KRAS G12C mutant advanced solid tumors.