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NOVEMBER 28, 2023

FDA Approves Nirogacestat for Desmoid Tumors

The FDA approved nirogacestat (Ogsiveo, SpringWorks Therapeutics) for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors, a rare subtype of soft tissue sarcomas.

Efficacy was evaluated in DeFi (ClinicalTrials.gov Identifier: NCT03785964), an international, multicenter, randomized (1:1), double-blind, placebo-controlled trial in 142 patients with progressing desmoid tumors not amenable to surgery. Patients were