FDA Grants SpringWorks’ Desmoid Tumor Drug Priority Review

The SpringWorks Therapeutics, a spinoff of Pfizer, received priority review by the US Food and Drug Admnistration (FDA) for nirogacestat as a treatment for desmoid tumors. Patients taking the small molecule drug as a monotherapy had 71% lower risk of progression and had a better objective response rate compared to placebo.

According to Max Gelman, “Nirogacestat is an oral small molecule gamma secretase inhibitor, spun out of Pfizer in September 2017 with a handful of other early-stage programs and $103 million in backing, including from two Bain funds. Its other late-stage candidate, a MEK inhibitor known as mirdametinib, could be submitted for approval in the first half of next year, analysts say.”

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(Source: Endpoints News, February 27^th, 2023)