FDA Grants Priority Review to Ruxolitinib for Acute GVHD
The Food and Drug Administration has granted a priority review to the supplemental new drug application for ruxolitinib (Jakafi) to treat patients with acute graft-versus-host-disease (GVHD) who have had an inadequate response to corticosteroids.
The Food and Drug Administration (FDA) has granted a priority review to ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host-disease (GVHD) who have had an inadequate response to corticosteroids.
“Patients with acute GVHD face significant morbidity and mortality risk, underscoring the urgent need for new treatment options,” Steven Stein, MD, chief medical officer of Incyte, the drug’s manufacturer, said in a press release.
In the supplemental new drug application for ruxolitinib, Incyte included data from the REACH1 study, which investigated ruxolitinib in combination with corticosteroids in 71 patients with acute GVHD who have had an inadequate response to corticosteroids.
Topline results from the ongoing trial demonstrated an overall response rate of 55% (n = 39) at day 28, the primary endpoint. In addition, the best overall response rate was 73% (n = 52).
“If approved, ruxolitinib will be the first and only treatment available in the US for patients with acute GVHD who have not responded adequately to corticosteroid therapy,” Stein said.
BLA Resubmission Accepted by the FDA for Remestemcel-L in Pediatric Steroid-Refractory aGVHD
August 11th 2024The biologics license application that was resubmitted for remestemcel-L has been accepted by the FDA for the potential treatment of children with steroid-refractory acute graft-vs-host-disease.
