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FDA Extends Review Period for Ruxolitinib in GVHD

Jason M. Broderick @jasoncology
Published: Thursday, Feb 07, 2019

Steven Stein from Incyte

Steven Stein, MD

The FDA has added 3 months to the review period for a supplemental new drug application (sNDA) for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease (aGVHD) who have had an inadequate response to corticosteroids, making the new action date May 24, 2019.

The ongoing REACH program also includes the phase III REACH2 trial (NCT02913261), comparing ruxolitinib versus best available therapy in patients with corticosteroid-refractory aGVHD after ASCT, as well as the phase III REACH3 trial (NCT03112603) examining ruxolitinib versus best available therapy in patients with corticosteroid-refractory chronic GVHD after bone marrow transplantation.
Jagasia M, Perales M-A, Schroeder MA, et al. Results from REACH1, a single-arm phase 2 study of ruxolitinib in combination with corticosteroids for the treatment of steroid-refractory acute graft-vs-host disease. Presented at: 2018 ASH Annual Meeting; December 1-4, 2018; San Diego, CA. Abstract 601.

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