On Mirati 19, 2022 Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for adagrasib for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation who have received at least one prior systemic therapy (Press release, Mirati, MAY 19, 2022, View Source [SID1234614892]).
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The MAA is supported by data from the registration enabling cohort of the Phase 2 KRYSTAL-1 study evaluating adagrasib 600mg BID in patients with advanced NSCLC harboring the KRASG12C mutation following prior treatment with immunotherapy and chemotherapy, either together or sequentially. The Company reported positive topline data from this cohort in September 2021 and plans to present detailed results at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
"The submission of our application to the EMA is a significant milestone for Mirati and brings us closer to expanding the potential availability of adagrasib to patients with KRASG12C-mutated lung cancer in the European Union, if approved," said Charles Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "Therapeutic options for KRASG12C-mutated lung cancer are limited, and this submission is an important step forward in our goal to deliver innovative, differentiated therapies in areas of high unmet need. We look forward to working with the EMA to potentially bring this therapy to patients. We also thank the patients and investigators who make our work possible by participating in clinical trials."
The adagrasib New Drug Application (NDA) is currently being reviewed by the U.S. Food and Drug Administration (FDA) for Accelerated Approval (Subpart H) as a treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy. The application is being reviewed under the FDA Real Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Adagrasib has also achieved Breakthrough Therapy Designation in the U.S. as a potential treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy.
About Adagrasib (MRTX849)
Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24–48 hours. Adagrasib 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 cancer (NSCLC), colorectal cancer and pancreatic cancer. For more information visit Mirati.com/science.
Mirati has an Expanded Access Program (EAP) for investigational adagrasib for the treatment of eligible patients with KRASG12C-mutated cancers, regardless of tumor type, in the U.S. Learn more about the EAP at Mirati.com/expanded-access-policy.