Incyte announces acceptance and priority review of sNDA for Jakafi as a treatment for patients with chronic graft-versus-host disease.

Incyte has announced that the FDA has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi) for treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. The sNDA submission is based on results from the Phase III, randomized REACH3 study comparing ruxolitinib with best available therapy (BAT) in patients with steroid-refractory chronic GVHD. In the REACH3 study, which was recently presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, patients treated with ruxolitinib experienced a significantly greater overall response rate (ORR) compared to BAT at Week 24, the primary endpoint (49.7% vs. 25.6%; p<0.0001). for the key secondary endpoints, ruxolitinib was associated with a longer median failure-free survival (ffs) than bat at week 24 (not reached vs. 5.7 months; hazard ratio (hr), 0.370; p><0.0001), and greater symptom improvement per the modified lee symptom scale (mlss) at week 24 (24.2% vs. 11.0%; odds ratio (or), 2.62; p="0.0011)." the best orr for patients receiving ruxolitinib was 76.4%. no new safety signals were observed, and adverse events were consistent with the known safety profile of ruxolitinib. the prescription drug user fee act (pdufa) target action date for jakafi in steroid-refractory chronic gvhd is june 22, 2021..>