The FDA has accepted for review Mirati Therapeutics Inc's (NASDAQ:MRTX) marketing application seeking approval for adagrasib for non-small cell lung cancer (NSCLC).
- The application covers NSCLC patients harboring the KRASG12C mutation who have received at least one prior systemic therapy.
- The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022.
- The adagrasib NDA is being reviewed by the FDA for Accelerated Approval (Subpart H) and is being reviewed under the FDA Real-Time Oncology Review (RTOR) pilot program.
- The application is based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, evaluating adagrasib 600mg BID in patients.
- The Company reported positive topline data from this cohort in September 2021 and plans to present detailed results at a medical conference during 1H of 2022.
- The Company has an ongoing confirmatory Phase 3 trial, KRYSTAL-12, evaluating adagrasib versus docetaxel in patients with second-line KRASG12C-mutated NSCLC.
- Price Action: MRTX shares are down 7.81% at $99.00 during the premarket session on the last check Wednesday.
