'Breakthrough' status for SpringWorks' nirogacestat

29 August 2019

The US Food and Drug Administration has granted Breakthrough Therapy designation for nirogacestat, an oral, selective, small molecule, gamma-secretase inhibitor, for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis, says USA-based biopharma firm SpringWorks Therapeutics.

The Breakthrough Therapy designation, which is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition, was based on Phase I and Phase II data evaluating nirogacestat as a monotherapy in patients with desmoid tumors.

Currently enrolling adult patients in Phase III DeFi trial

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