The FDA has granted accelerated approval to adagrasib with cetuximab for the treatment of KRASG12C -mutated locally advanced or metastatic colorectal cancer, according to a press release from the agency.
The approval was based on results from the KRYSTAL-1 multicenter, single-arm expansion cohort trial, which included 94 patients with KRASG12C-mutated colorectal cancer who had previously been treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based therapy.
The overall response rate of adagrasib (Krazati; Mirati Therapeutics Inc.) plus cetuximab (Erbitux; Imclone) was 34% (95% CI,