Therapeutic Response

KRAS p.G12C status confers therapeutic sensitivity to Adagrasib in combination with Cetuximab in patients with Colorectal Adenocarcinoma.

Statements

Source and description

Krazati (adagrasib) [package insert]. FDA. The U.S. Food and Drug Administration (FDA) granted accelerated approval to adagrasib in combination with cetuximab for the treatment of adult patients 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. The product label notes that this indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) and that continued approval for this indications may be contingent upon verification and description of a clinical benefit in confirmatory trials.