FDA Accepts New Drug Application for Mirati's KRAS Inhibitor

▎WuXi AppTec Content Team Editor Mirati Therapeutics announced today that the U.
S.
Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for the KRAS G12C inhibitor adagrasib, for the treatment of patients with KRAS G12C mutation non-small cell lung cancer (NSCLC)
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They had received at least one prior systemic therapy
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The PDUFA date for this application is December 14, 2022
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The release states that the FDA's review of adagrasib will use the accelerated approval pathway, which allows the FDA to use surrogate endpoints to approve innovative drugs that treat serious diseases and address unmet needs
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And, the application will use the FDA's Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to get safe and effective drugs into patients' hands sooner
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Adagrasib is a highly specific and potent oral KRAS G12C inhibitor optimized for durable target inhibition
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Adagrasib has a half-life of up to 24 hours, broad tissue distribution, and its ability to cross the blood-brain barrier, helping to maximize drug efficacy
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In June last year, the U.
S.
Food and Drug Administration granted it breakthrough therapy designation for the treatment of previously treated non-small cell lung cancer patients with the KRAS G12C mutation
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In China, Zai Lab owns the development rights of this innovative therapy in Greater China, and the clinical trial application jointly submitted with Mirati was accepted on November 1 last year
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▲Design features of Adagrasib (Image source: Mirati’s official website) This NDA is based on the cohort results of adagrasib in the KRYSTAL-1 Phase 2 clinical trial that supports registration
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In patients with advanced NSCLC harboring a KRAS G12C mutation, adagrasib achieved an objective response rate (ORR) of 43% and a disease control rate (DCR) of 80%
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It is worth mentioning that 98.
3% of the patients had received chemotherapy and immunotherapy
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"The FDA acceptance of our NDA for adagrasib is an important step forward for Mirati in developing innovative and differentiated treatment options for KRAS G12C cancer patients
,
" said Dr.
Charles Baum, Mirati's founder and head of research and development.
The FDA collaborated during the review process to provide an innovative option for patients with non-small cell lung cancer
.

"Reference: [1] US Food and Drug Administration (FDA) Accepts Mirati Therapeutics' New Drug Application for Adagrasib as Treatment of Previously Treated KRASG12C-Mutated Non-Small Cell Lung Cancer.
Retrieved February 15, 2022, from https:// mutated-non-small-cell-lung-cancer-301483014.
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