FDA OKs Cogent NDA for bezuclastinib plus sunitinib in previously treated GIST, grants Priority Review

 

• FDA set a PDUFA target action date of November 30, 2026 for the application.
• No FDA advisory committee meeting is currently planned for the bezuclastinib plus sunitinib NDA.
• FDA has not identified any review issues to date for the bezuclastinib plus sunitinib submission.

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