
FDA Grants Ruxolitinib Priority Review to Treat Chronic GVHD
The FDA has granted priority review of the supplemental New Drug Application for ruxolitinib for the treatment of steroid-refractory chronic graft-versus host disease (GVHD).
The FDA has granted priority review of the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi) for the treatment of
At the American Society of Hematology (ASH) Annual Meeting & Exposition, held in December 2020, Incyte had
“Chronic GVHD is a life-threatening complication following stem cell transplant that burdens a vulnerable patient population, which today has limited treatment options,” Peter Langmuir, MD, group vice president, oncology targeted therapies, Incyte,
According to the researchers, ruxolitinib demonstrated a superior efficacy. Failure-free survival (FFS) was significantly longer for patients treated with ruxolitinib: the median FFS was not reached for the ruxolitinib arm compared with 5.7 months for the BAT arm (HR, 0.370 [95% CI, 0.268-0.510]; P < .0001).
Ruxolitinib also had a superior overall response rate (ORR) at week 24, the primary end point of the trial. The ORR for patients taking ruxolitinib was 50% vs 26% for the BAT arm (odds ratio, 2.99; P < .0001).
“Based on the compelling REACH3 results, we now have a potential new standard of care for these patients,” presenting author Robert Zeiser, MD, of the University Hospital Freiburg, in Freiburg, Germany,
The target Prescription Drug User Fee Act action date for Jakafi is June 22, 2021.
Reference
Zeiser R, Polverelli N, Ram R, et al. Ruxolitinib (RUX) vs best available therapy (BAT) in patients with steroid-refractory/steroid-dependent chronic graft-vs-host disease (cGVHD): primary findings from the phase 3, randomized REACH3 study. Presented at the 62nd American Society of Hematology Annual Meeting and Exposition, Virtual; December 5-8, 2020; Abstract 77.
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