The Food and Drug Administration (FDA) has granted Fast Track designation to nirogacestat, an investigational oral treatment for adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.
Nirogacestat, a selective gamma-secretase inhibitor, has been investigated in 24 patients with desmoid tumors across Phase 1 and Phase 2 studies; the Company is planning a Phase 3 study (DeFi) sometime in the first half of 2019. “We look forward to continuing to work closely with the FDA throughout our development program with the hope of ultimately bringing this important medicine to patients,” said Saqib Islam, CEO of SpringWorks Therapeutics.
Desmoid tumors are rare, non-metastatic tumors of connective tissue cells; the most common sites for tumors include upper and lower extremities, abdominal walls, thoracic area, and the head and neck. According to the US National Library of Medicine, National Institutes of Health, there are 900 to 1500 new cases diagnosed each year in the US.
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