BRIEF—SpringWorks completes US submission for nirogacestat

SpringWorks Therapeutics has completed the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for nirogacestat, an investigational gamma secretase inhibitor.

The company is seeking approval to market the therapy for the treatment of adults with desmoid tumors, a rare and aggressive form of tumor.

The agency is reviewing the submission, which includes data from the Phase III DeFi trial, under the Real-Time Oncology Review (RTOR) program.

The treatment is an oral, selective gamma secretase inhibitor which has secured Fast Track and Breakthrough Therapy designations in this indication, as well as Orphan Drug designation.

Chief executive Saqib Islam said: “Nirogacestat holds tremendous potential to address the substantial unmet needs that remain for people living with desmoid tumors and the submission of our NDA represents an important step toward our goal of delivering the first approved therapy to treat this devastating disease.”