SpringWorks Therapeutics Receives the US FDA Approval for Ogsiveo (nirogacestat) for the Treatment of Desmoid Tumors
Shots:
- The approval was based on the P-III study (Defi) evaluating nirogacestat, vs PBO on Desmoid Tumor patients (n=142). The study met its 1EP depicted improved PFS & 71% reduction in disease progression
- Based on RECIST v1.1 ORR was 41% vs 8%; the complete response rate was 7% vs 0%; mDoR was 5.6 vs 11.1mos. Additionally, median PFS was not met in the nirogacestat arm & was 15.1mos. in PBO arm. Furthermore, Ogsiveo showed early & persistent benefits in patient-reported outcomes (PROs) such as pain, a symptom unique to desmoid tumors, role- & physical-functioning, & overall health-related quality of life
- The company anticipates submitting MAA for Ogsiveo, an oral, selective, small-molecule gamma-secretase inhibitor to the EMA in H1’24
Ref: SpringWorks | Image: SpringWorks
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
