SpringWorks Reports the Completion of NDA Submission to the US FDA for Nirogacestat to Treat Desmoid Tumors
- The company has completed the NDA submission of nirogacestat (gamma-secretase inhibitor) to the US FDA for desmoid tumors which are being reviewed under the US FDA’s RTOR program
- The submission incl. the P-III trial (DeFi) evaluating nirogacestat (150mg) vs PBO in a ratio (1:1) in 142 adult patients. The 1EPs were PFS or death by any cause. The 2EPs & exploratory EPs incl. safety & tolerability measures, ORR, DoR, changes in tumor volume & PROs
- Nirogacestat received ODD in the US & EU for desmoid tumors & soft tissue sarcoma; FTD & BTD for progressive, unresectable, recurrent, or refractory desmoid tumors or deep fibromatosis. SpringWorks collaborated with Fred Hutchinson Cancer Research Center & Dana-Farber Cancer Institute to characterize the ability of nirogacestat
Ref: Globenewswire | Image: SpringWorks Therapeutics
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