MRTX - Mirati Therapeutics' adagrasib gets FDA Breakthrough Therapy status

Mirati Therapeutics (MRTX) announces that the U.S. FDA has granted Breakthrough Therapy status to adagrasib for the potential treatment of patients with non-small cell lung cancer ((NSCLC)) who harbor the KRASG12C mutation following prior systemic therapy.Breakthrough Therapy is an FDA program designed to expedite the development and regulatory review of drugs that have demonstrated preliminary clinical evidence of a substantial improvement over available therapy in the treatment of patients with serious diseases on at least one clinically significant endpoint.The designation for adagrasib is supported by preliminary results from the registrational Phase 1/2 KRYSTAL-01 trial in patients with advanced NSCLC, whose cancer had progressed following prior treatment with immunotherapy and/or chemotherapy.Shares up nearly 6% post market.

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Mirati Therapeutics' adagrasib gets FDA Breakthrough Therapy status