FDA Grants Accelerated Approval to Krazati With Erbitux for KRAS G12C–Mutated Colorectal Cancer

The FDA has granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics) plus cetuximab (Erbitux, Lilly) for adults with KRAS G12C–mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

Efficacy was evaluated in KRYSTAL-1, a multicenter, single-arm expansion cohort trial. Eligible patients were required to have locally