FDA Approves First Treatment for Painful Non-Cancerous Tumors

The first drug to treat desmoid tumors shrank tumors in 41 percent of participants and improved quality of life with few side effects.

Connective tissue in microscope. Arkadiusz Wos/Shutterstock

A new therapy is now available to treat painful, non-cancerous desmoid tumors that grow in connective tissue, typically in the abdomen, arms and legs. These rare fibrous growths, also called aggressive fibromatosis, can now be treated Ogsiveo (or nirogacestat)—the first of its kind tablet approved by the U.S. Food and Drug Administration for adults who need systemic treatment.

The approval is marking a breakthrough for patients with desmoid tumors seeking alternatives to surgery, according to Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

Why Is a New Treatment Needed?

Desmoid tumors are benign growths that often invade surrounding tissue and organs. This leads to severe pain, impaired mobility, and reduced quality of life. In extreme cases, these tumors can cause nerve damage, bowel perforations, amputations, and other serious complications.