SpringWorks Therapeutics, Inc. (SWTX) announced Monday that the U.S. Food and Drug Administration has accepted its New Drug Application or NDA for nirogacestat, an investigational gamma secretase inhibitor, for the treatment of adults with desmoid tumors.
The clinical-stage biopharmaceutical company focused on severe rare diseases and cancer noted that the NDA was granted Priority Review and has been given a Prescription Drug User Fee Act (PDUFA) action date of August 27.
The FDA’s Priority Review designation is given to investigational medicines that treat a serious condition.
The NDA is being reviewed under the FDA’s Real-Time Oncology Review program and is based on the previously announced positive results from the Phase 3 DeFi trial.
The study was a global, randomized, double-blind, placebo-controlled trial evaluating nirogacestat in adult patients with desmoid tumors.
In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.
Saqib Islam, Chief Executive Officer of SpringWorks, said, “The acceptance of our NDA for nirogacestat with Priority Review represents a significant milestone in our ambition to provide the first approved therapy for patients with desmoid tumors.”
The FDA 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.
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