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# FDA Accepts Mirati Adagrasib NDA
- URL: https://www.fdaweb.com/fda-accepts-mirati-adagrasib-nda/
- Published: 2022-02-15T12:00:00.000Z
- Updated: 2026-09-14T17:32:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151166

FDA has accepted a Mirati Therapeutics NDA for adagrasib to treat patients with non-small-cell lung cancer with the KRASG12C mutation who have received at least one prior systemic therapy. The company [says](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=newssearch&cd=&cad=rja&uact=8&ved=2ahUKEwjY6ZHZ1YL2AhW3kokEHWtgBm8QxfQBKAB6BAgPEAI&url=https%3A%2F%2Fwww.prnewswire.com%2Fnews-releases%2Fus-food-and-drug-administration-fda-accepts-mirati-therapeutics-new-drug-application-for-adagrasib-as-treatment-of-previously-treated-krasg12c-mutated-non-small-cell-lung-cancer-301483014.html&usg=AOvVaw34YZxiQJUdDBwpi-ZMgVdW) the PDUFA action date was set at 12/14.

The NDA is being reviewed for accelerated approval and under the Real-Time Oncology Review pilot program. Adagrasib has been given a breakthrough therapy designation.

Mirati describes adagrasib as an investigational highly sensitive and potent oral small molecule inhibitor of KRASG12C that is optimized to sustain target inhibition. It is being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C\-mutated solid tumors, including non-small-cell lung, colorectal, and pancreatic cancers.