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