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MRTX 849 filed with EU for non-small cell lung cancer with the KRASG12C mutation.- Mirati Therapeutics

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Published:21st May 2022

Mirati Therapeutics announced that it has submitted a Marketing Authorization Application to the European Medicines Agency for MRTX 849 (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.

 

The MAA is supported by data from the registration enabling cohort of the Phase II 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) Annual Meeting.

The adagrasib New Drug Application is currently being reviewed by the 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 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.

Condition: NSCLC/KRAS G12C
Type: drug

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