FDA Approves First KRAS-Targeted Therapy, Lumakras, for NSCLC
Posted by Charles Decuir on June 7, 2021 3:30 PM EDT
The FDA granted accelerated approval to the RAS GTPase inhibitor sotorasib (Lumakras, Amgen) for the treatment of adults 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 is the first approved targeted therapy for tumors with any KRAS mutation, which accounts for approximately 25% of mutations in NSCLC. KRAS G12C mutations represent approximately 13% of mutations in NSCLC.
The agency also approved the QIAGEN Therascreen KRAS RGQ PCR kit (tissue) and the Guardant360 CDx (plasma) as companion diagnostics for use with sotorasib. If no mutation is detected in a plasma specimen, the tumor tissue should be tested.