FDA Approves KRAZATI® for KRAS G12C-Mutated Colorectal Cancer Treatment


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Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI® (adagrasib) in combination with cetuximab. This targeted treatment option is intended for adult patients diagnosed with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test.

The approval applies to patients who have previously received treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The combination of KRAZATI® and cetuximab offers a new therapeutic approach for this specific patient population, addressing a significant unmet need in the treatment of advanced or metastatic CRC.

The accelerated approval by the FDA underscores the importance of targeted therapies in the fight against colorectal cancer and highlights Bristol Myers Squibb’s commitment to developing innovative treatment options for patients with challenging-to-treat cancers.