SpringWorks Completes Submission Of Nirogacestat NDA To FDA For Desmoid Tumors Treatment

(RTTNews) - SpringWorks Therapeutics Inc. (SWTX) said it has completed the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for nirogacestat, an investigational gamma secretase inhibitor, for the treatment of adults with desmoid tumors.

The NDA submission is being reviewed under the FDA's Real-Time Oncology Review (RTOR) program and includes data from the Phase 3 DeFi trial, a global, randomized, double-blind, placebo-controlled trial in adult patients with desmoid tumors.

The FDA previously granted Fast Track and Breakthrough Therapy designations to nirogacestat for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. Nirogacestat has also received Orphan Drug designation from the FDA for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma.