SpringWorks Therapeutics has announced that it expects the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to deliver an opinion on its marketing authorization application (MAA) for nirogacestat by the second quarter of 2025. The application seeks approval for nirogacestat, an oral gamma secretase inhibitor, specifically aimed at treating adults with desmoid tumors.
The drug, developed by SpringWorks Therapeutics (SWTX, Financial), is designed to offer a new therapeutic option for managing this condition. Desmoid tumors are rare connective tissue tumors that can be aggressive and challenging to treat. The anticipated decision from the EMA's committee marks a significant step in the regulatory process.
