SpringWorks Therapeutics Nears EU Approval for First Desmoid Tumor Therapy, Nirogacestat

SpringWorks Therapeutics Inc. (NASDAQ:SWTX) is one of the best biotech stocks to invest in now. On June 20, SpringWorks Therapeutics announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use/CHMP adopted a positive opinion recommending the approval of nirogacestat. The oral gamma secretase inhibitor is proposed as a monotherapy for adults with progressing desmoid tumors who require systemic treatment.

The European Commission/EC is expected to review the CHMP opinion and make a decision regarding approval in Q3 2025. If approved, nirogacestat will be the first and only therapy with marketing authorization in the European Union for desmoid tumors. Nirogacestat previously received Orphan Drug designation from the EC for soft tissue sarcoma. The positive CHMP opinion was based on the Marketing Authorization Application/MAA for nirogacestat, which utilized results from the Phase 3 DeFi trial.

SpringWorks Therapeutics Nears EU Approval for First Desmoid Tumor Therapy, Nirogacestat

A closeup of a scientist in a lab coat, mixing two liquids for a compound to treat rare diseases.

The results were published in The New England Journal of Medicine. In the DeFi trial, nirogacestat met its primary endpoint by improving progression-free survival/PFS, which showed a 71% lower risk of disease progression compared to placebo. The trial also showed a significant improvement in objective response rate and early, sustained improvements in patient-reported outcomes, including pain, physical functioning, and overall quality of life. The safety and tolerability profile of nirogacestat was manageable.

SpringWorks Therapeutics Inc. (NASDAQ:SWTX) is a commercial-stage biopharmaceutical company that develops and commercializes medicines for underserved patient populations suffering from rare diseases and cancer.

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Disclosure: None. This article is originally published at Insider Monkey.