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Bottles of ruxolitinib
The U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for the JAK1/JAK2 inhibitor ruxolitinib (Jakafi®).
With this sNDA, Incyte Corporation is seeking approval for ruxolitinib as a treatment for patients with acute graft-versus-host-disease (GVHD) who have had an inadequate response to corticosteroids.
“If approved, ruxolitinib will be the first and only treatment available in the U.S. for patients with acute GVHD who have not responded adequately to corticosteroid therapy,” said Steven Stein, MD, chief medical officer at Incyte.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The agency intends to take action on a priority review application within 6 months of receiving it rather than the standard 10 months.
In addition to priority review, ruxolitinib has received breakthrough therapy and orphan drug designations from the FDA as a treatment for acute GVHD.
The sNDA submission for ruxolitinib in acute GVHD is based on data from the phase 2 REACH1 trial (NCT02953678).
In this ongoing trial, researchers are evaluating ruxolitinib in combination with corticosteroids in patients who have steroid-refractory acute GVHD.
Incyte announced topline results from REACH1 in June, reporting on outcomes in 71 patients.
The study’s primary endpoint—overall response rate at day 28—was met. Ruxolitinib produced an overall response rate of 55% (39/71) at that time.
However, 73% of patients (52/71) responded to ruxolitinib at some point during the trial.
Incyte said the most common treatment-emergent adverse events were anemia (61%), thrombocytopenia (61%), and neutropenia (56%).