SpringWorks Therapeutics announces PDUFA date extension for nirogacestat NDA to treat Desmoid tumour.

The previously disclosed August 27, 2023 PDUFA date has been extended by the standard extension period of three months.

The FDA notified SpringWorks on June 2, 2023 that it required more time to review additional analyses of previously submitted data that had been provided by SpringWorks in response to the FDA’s information requests. The submission of this additional information was determined by the FDA to constitute a Major Amendment to the NDA, thereby resulting in an extension of the PDUFA action date. No additional data or studies have been requested by the FDA at this time.

The NDA for nirogacestat was granted Priority Review upon its acceptance by the FDA in February 2023 and is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program. It is based on positive data from the Phase III DeFi trial which were published in the March 9, 2023 edition of the New England Journal of Medicine.(previously cited) . The FDA previously granted Breakthrough Therapy, Fast Track and Orphan Drug designations for nirogacestat. In addition, SpringWorks expects to file a Marketing Authorization Application for nirogacestat with the European Medicines Agency in 2024.