Mirati Therapeutics' Adagrasib Application Under FDA Review For Lung Cancer Setting

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.