Posted by Michael Wonder on 27 Dec 2022
SpringWorks Therapeutics completes submission of new drug application to the FDA for nirogacestat for the treatment of adults with desmoid tumours
27 December 2022 - SpringWorks Therapeutics announced today that the Company has completed the submission of a new drug application to the US FDA for nirogacestat, an investigational gamma secretase inhibitor, for the treatment of adults with desmoid tumours.
The submission is being reviewed under the FDA’s Real-Time Oncology Review program and includes data from the Phase 3 DeFi trial, a global, randomised, double-blind, placebo-controlled trial in adult patients with desmoid tumours.
