Shots:
- The CHMP has recommended Nirogacestat as a monotx. for adults with progressing desmoid tumors needing systemic treatment, the EC’s decision is expected in Q3’25
- Opinion was supported by the MAA on P-III (DeFi) global trial (N=142) assessing Nirogacestat (n=700) vs PBO (n=72), which met the 1EP, showing a 71% reduction in PFS vs PBO, along with significant improvements in exploratory & 2EPs (ORR and PROs); published in the NEJM
- Nirogacestat (150mg; BID) is an oral, small-molecule gamma-secretase inhibitor approved in the US for adults with progressing desmoid tumors requiring systemic treatment
Ref: SpringWorks Therapeutics | Image: SpringWorks Therapeutics | Press Release
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