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FDA Grants Priority Review to Ruxolitinib for GVHD

Jason M. Broderick @jasoncology
Published: Friday, Oct 26, 2018

Steven Stein from Incyte

Steven Stein, MD

The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids, according to Incyte, the manufacturer of the JAK1/JAK2 inhibitor.

Incyte reported in a press release that the full data from REACH1 will be presented at an upcoming medical conference. The FDA previously granted ruxolitinib a breakthrough therapy designation in this setting. Under the priority review, the FDA acts within 6 months of receiving a supplemental application, rather than the standard 10 months.

“Patients with acute GVHD face significant morbidity and mortality risk, underscoring the urgent need for new treatment options,” Steven Stein, MD, chief medical officer, Incyte, said in a statement. “If approved, ruxolitinib will be the first and only treatment available in the United States for patients with acute GVHD who have not responded adequately to corticosteroid therapy. The acceptance of our sNDA is a critical milestone for Incyte and the GVHD community, and we look forward to working with the FDA to bring this innovative therapy to patients who currently have limited treatment options as soon as we are able.”
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