U.S. Food and Drug Administration Approves Ruxolitinib (JAKAFI) for Acute Graft-Versus-Host Disease

On May 24, 2019, the U.S. Food and Drug Administration (FDA) announced it has approved the use of ruxolitinib (JAKAFI, Incyte Corporation) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

The approval was based on Study INCB 18424-271 (NCT02953678), an open-label, single-arm, multicenter study of ruxolitinib that enrolled 49 patients with steroid-refractory acute GVHD Grades 2 to 4. Ruxolitinib was administered at 5 mg twice daily, and the dose could be increased to 10 mg twice daily after 3 days in the absence of toxicity.

The FDA granted this application priority review. A description of the FDA expedited programs can be found here.

“The approval for ruxolitinib is an important advancement for patients suffering from steroid-refractory acute graft-versus-host disease,” said Meghan Gutierrez, Chief Executive Officer at the Lymphoma Research Foundation. “This serious condition previously had limited treatment options, and this approval not only represents an additional therapy for graph-verses-host-disease, but a hope for both younger and older patients.”

For more information on this FDA approval visit the FDA’s website.

Kinya P. Harte
Director of Communications and Marketing