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David S. Ettinger, MD, FACP, FCCP


FDA Brief: New Drug Application Accepted for Adagrasib in KRAS G12C–Mutated NSCLC

By: JNCCN 360 Staff
Posted: Friday, February 18, 2022

On February 15, Mirati Therapeutics announced that the U.S. Food and Drug Administration (FDA) accepted the new drug application for adagrasib in the treatment of patients with non–small cell lung cancer (NSCLC) harboring the KRAS G12C mutation who have received at least one prior systemic therapy. Adagrasib is an investigational, oral, small-molecule inhibitor of KRAS G12C. It is being evaluated as monotherapy and in combination with other anticancer therapies in patients with advanced KRAS G12C–mutated solid tumors, including NSCLC, colorectal cancer, and pancreatic cancer.

The new drug application is based on the phase II registration-enabling cohort of the KRYSTAL-1 study. This trial is evaluating adagrasib at 600 mg twice daily in patients with advanced NSCLC harboring the KRAS G12C mutation following prior treatment with immunotherapy and chemotherapy, either together or sequentially. An ongoing confirmatory phase III trial, KRYSTAL-12, is evaluating adagrasib versus docetaxel in the second-line setting for patients with KRAS G12C–mutated NSCLC.

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