FDA Greenlights Groundbreaking Treatment for Uncommon Benign Tumors

The FDA has approved Ogsiveo (nirogacestat) tablets as the first therapy for adult patients with progressing desmoid tumors, a rare type of non-cancerous tumor. Desmoid tumors can be locally aggressive and cause pain and decreased quality of life. Ogsiveo demonstrated significant improvement in progression-free survival and tumor shrinkage compared to placebo in clinical trials. Common side effects include diarrhea, ovarian toxicity, rash, and nausea. Ogsiveo received Priority Review, Fast Track, Breakthrough Therapy, and Orphan-Drug designations.