▎WuXiEdited by Kant Content Team

Bristol-Myers Squibb today announced that the U.S. FDA has accepted its KRAS G12C inhibitor Krazati (adagrasib) in combination with cetuximab for the treatment of tumors withKRAS Supplemental New Drug Application (sNDA) for G12C-mutant previously treated advanced or metastatic colorectal cancer (CRC) has been granted Priority Review. The PDUFA goal date for this application is June 21, 2024.

The submission of this sNDA is primarily based on the results of the KRYSTAL-1 study, a multi-cohort trial that evaluated Krazati as a monotherapy or in combination with other anticancer therapies for the treatment of patients carryingKRAS Efficacy and Safety in Patients with G12C-Mutant Advanced Solid Tumors. The primary endpoint of the trial is the objective response rate, with secondary endpoints including duration of response, progression-free survival, overall survival, and safety.

The results of the KRYSTAL-1 study indicate that,Krazati was well tolerated and in carriersKRAS G12C-mutant locally advanced or metastatic previously treated CRC patients showed promising clinical activity.The safety of Krazati and cetuximab is controllable and consistent with previous trials and the known safety profiles of each drug.

Krazati is a highly specific and potent oral KRAS G12C inhibitor., which has been optimized to possess durable target inhibition capabilities.Krazati has a half-life of up to 24 hours and extensive tissue distribution, and it can cross the blood-brain barrier, which helps maximize drug efficacy.In June 2021, the U.S. FDA granted it Breakthrough Therapy designation, and it was approved by the FDA for marketing in December 2022, for the treatment of patients carryingKRAS Patients with G12C-mutant non-small cell lung cancer who have been treated, during the same period, Zai Lab obtainedadagrasibResearch, development, production, and exclusive commercial rights in Greater China.

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References:

[1] U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for KRAZATI® (adagrasib) in Combination with Cetuximab as a Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or... Retrieved February 20, 2024 from https://news.bms.com/news/details/2024/U.S.-Food-and-Drug-Administration-FDA-Accepts-Supplemental-New-Drug-Application-for-KRAZATI-adagrasib-in-Combination-with-Cetuximab-as-a-Targeted-Treatment-Option-for-Patients-with-Previously-Treated-KRAS-G12C-Mutated-Locally-Advanced-or/default.aspx

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