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SpringWorks Therapeutics Reports the US FDA Acceptance of NDA and Granted Priority Review of Nirogacestat for Desmoid Tumors

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SpringWorks Therapeutics

SpringWorks Therapeutics Reports the US FDA Acceptance of NDA and Granted Priority Review of Nirogacestat for Desmoid Tumors

Shots:

  • The US FDA has accepted the NDA for nirogacestat in adults with desmoid tumors. The application also granted priority review with an expected PDUFA date of Aug 27, 2023
  • The NDA was based on the P-III trial (DeFi) results evaluating nirogacestat (150mg) vs PBO in a ratio (1:1) in 142 patients. The 1EPs were PFS or death by any cause while the 2EPs & exploratory EPs incl. safety & tolerability measures, ORR, DoR, changes in tumor volume as assessed by MRI & changes in PROs
  • Nirogacestat is an oral, selective, small molecule gamma-secretase inhibitor & has received FTD & BTD from the US FDA for progressive, unresectable, recurrent, or refractory desmoid tumors or deep fibromatosis; ODD from the US FDA for desmoid tumors & from EC for soft tissue sarcoma

Ref: Globenewswire | Image: SpringWorks Therapeutics

Related News:- SpringWorks Reports the Completion of NDA Submission to the US FDA for Nirogacestat to Treat Desmoid Tumors

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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