Immunome files FDA application for varegacestat in desmoid tumors

Immunome said it has submitted a new drug application to the US FDA for varegacestat, a once-daily oral gamma secretase inhibitor, to treat adults with progressing desmoid tumors. The filing is backed by the phase 3 RINGSIDE trial, where varegacestat reduced the risk of progression or death versus placebo by 84% and delivered a 56% objective response rate, compared with 9% for placebo. The company announced the submission on April 29, 2026, positioning varegacestat as a potential new entrant in a small but increasingly active desmoid tumor treatment space. (nasdaq.com)

Why it matters: For veterinary professionals tracking comparative oncology and rare tumor therapeutics, this is another sign that gamma secretase inhibition is becoming more established in desmoid tumors. The FDA already approved nirogacestat, sold as Ogsiveo, in November 2023 as the first treatment for adults with progressing desmoid tumors, so varegacestat would enter a market with an existing class precedent rather than break entirely new ground. That could sharpen attention on dosing convenience, safety, fertility-related adverse effects, and how clinicians differentiate between agents in the same class. (fda.gov)

What to watch: The next step is the FDA’s initial filing review, typically within about 60 days, followed by a formal review timeline if the application is accepted. (dtrf.org)