Posted by Michael Wonder on 07 Nov 2018
SpringWorks Therapeutics receives FDA fast track designation for nirogacestat for the treatment of adult patients with desmoid tumours
7 November 2018 - SpringWorks Therapeutics today announced that the U.S. FDA has granted fast track designation for nirogacestat, an investigational, oral, small molecule, selective gamma-secretase inhibitor, for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumours or deep fibromatosis.
In June 2018, the U.S. FDA granted orphan drug designation for nirogacestat for the treatment of desmoid tumours. SpringWorks expects to initiate the DeFi Study, a global Phase 3, double-blind, randomised, placebo-controlled trial in patients with desmoid tumours in the first half of 2019.
