The FDA has accepted and granted priority review to a supplemental new drug application (sNDA) for the first-in-class JAK1/JAK2 inhibitor ruxolitinib (Jakafi) for the treatment of steroid-refractory chronic graft-versus-host disease (cGVHD) in adult and pediatric patients 12 years and older, according to the drug’s developer, Incyte.1
A prescription drug user fee act (PDUFA) target action date has been set by the FDA for June 22, 2021.
The submission is being reviewed as part of the Project Orbis program, an initiative of the United States FDA Oncology Center of Excellence that “provides a framework for concurrent submission and review of oncology drugs among international regulatory agencies.” Countries participating for this particular application include Canada, Australia, Switzerland, Brazil, and the United Kingdom.
“Chronic GVHD is a life-threatening complication following…
