FDA Approves Ruxolitinib for Patients with Chronic Graft-Versus-Host Disease

The Food and Drug Administration (FDA) has approved ruxolitinib (Jakafi) for the treatment of chronic graft-versus-host disease after the failure of 1 or 2 lines of systemic therapy.

The approval, awarded to Incyte, is indicated for adults and pediatric patients 12 years and older.

The FDA also approved ruxolitinib for patients 12 years and older for mild-to-moderate atopic dermatitis.

The approval followed data pulled from phase 3 of the REACH3 study, a randomized, open-label, multicenter study that compared data on ruxolitinib and the best available therapy (BAT) for treatment of steroid-refractory chronic graft-versus-host disease after allogeneic stem cell transplantation

Chronic-graft-versus-host disease has been cited as the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant.

The overall response rate at the end of the study was 49.7% for ruxolitinib and 25.6% for BAT.

An Incyte press release cited this as the fourth approval granted for ruxolitinib in the US.

“In the U.S., there are over 14,000 people living with chronic GVHD, many of whom face significant complications that may impair daily activities and linger for years,” said Susan Stewart, Executive Director, BMT InfoNet. “The approval of Jakafi is an exciting development for the GVHD community and an important step forward in the treatment of a disease with few options.”