FDA Approves Adagrasib for KRAS G12C–Mutated CRC

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The FDA granted accelerated approval to Adagrasib (Krazati) with cetuximab for patients with KRAS G12C–mutated colorectal cancer who previously received certain chemotherapy treatments. Adagrasib is the first KRAS inhibitor approved for colorectal cancer, also approved for non-small cell lung cancer based on positive trial findings. The recommended dose is 600 mg taken orally twice daily until disease progression or unacceptable toxicity. Common adverse reactions include rash, nausea, diarrhea, and fatigue. The approval provides a new treatment option for patients with poor prognoses, with potential benefits demonstrated in the KRYSTAL-1 trial. The drug application for priority review was accepted in 2023.

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