FDA to quickly review Incyte’s Jakafi in chronic GVHD

The FDA is to begin a fast review of Incyte’s Jakafi (ruxolitinib) for patients with chronic graft-versus-host disease (GVHD), which cannot be treated with steroids.

The US pharma, which has partnered with Novartis to develop this first-in-class JAK1/JAK2 inhibitor, said the FDA will review data from the phase 3 REACH 3 study comparing Jakafi to best available therapy in patients aged 12 years and older with steroid refractory GVHD.