FDA Extends Review for Incyte’s Jakafi for GVHD

The FDA has pushed back its review of Incyte’s Janus kinase (JAK) inhibitor Jakafi (ruxolitinib) for treating patients with steroid-refractory chronic graft-vs.-host disease (GVHD).

The agency set a revised PDUFA target action date of Sept. 22, extending its review of the supplemental New Drug Application (sNDA) by three months, after the agency deemed additional data submitted by Incyte to be “a major amendment to the sNDA,” the company said.

The phase 3 trial data showed Jakafi demonstrated a superior overall response at week 24 vs. best available therapy in GVHD patients 12 years and older. The company is “confident” in the late-stage study results and looks forward to continued discussions with the FDA, said Steven Stein, Incyte’s chief medical officer.