SpringWorks Therapeutics Receives EC Approval for OGSIVEO

Approval of OGSIVEO: SpringWorks Therapeutics received marketing authorization from the European Commission for OGSIVEO, an oral gamma secretase inhibitor, as a treatment for adults with progressing desmoid tumors requiring systemic therapy.

Clinical Trial Results: The approval is based on the Phase 3 DeFi trial results, which showed that OGSIVEO significantly improved progression-free survival compared to placebo, with a 71% reduction in disease progression risk.

Response Rates: OGSIVEO achieved a confirmed objective response rate of 41%, compared to 8% for placebo, and demonstrated quicker responses, with a median time to first response of 5.6 months versus 11.1 months for placebo.

Safety Profile: OGSIVEO exhibited a manageable safety profile, with common adverse reactions including diarrhea, rash, nausea, and fatigue reported among patients in clinical studies.