Immunome announced the acceptance of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for varegacestat, a once-daily oral gamma-secretase inhibitor (GSI) for adults living with desmoid tumors.
Why is this milestone important?
For patients and families navigating this rare and often unpredictable disease, continued progress in research and drug development is critical. While U.S. FDA review is still ahead, this acceptance reflects growing momentum across the field and reinforces the importance of collaboration between researchers, industry, and the patient community.
What happens next?
The FDA will now conduct a comprehensive, multidisciplinary evaluation of the therapy’s safety, efficacy, and manufacturing quality typically follows over the next 6 to 10 months. This process may include inspections and, in some cases, an advisory committee review.
The Desmoid Tumor Research Foundation (DTRF) is deeply grateful to the Immunome team and everyone who helped bring this moment closer. We look forward to the progress ahead for people living with desmoid tumors.
Read Immunome’s full press release below:
