Mirati (MRTX) is developing adagrasib as a potential treatment for patients suffering from non-small cell lung cancer with KRAS mutation. An NDA is expected to be filed in the second half of 2021.
The FDA has granted Breakthrough Therapy designation to Mirati Therapeutics Inc's (NASDAQ: MRTX) adagrasib in non-small cell lung cancer (NSCLC) patients with the KRAS-G12C mutation. The decision was based on preliminary results from the Phase 1/2 KRYSTAL-01 trial in patients with advanced NSCLC whose cancer had progressed following prior treatment with immunotherapy or chemotherapy. According to data presented in October, 45% of patients saw an objective response. Those numbers come from a pool
Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to adagrasib for the potential treatment of patients with non-small cell lung cancer (NSCLC) who harbor the KRASG12C mutation following prior systemic therapy.