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On May 5, 2022, the European Commission announced the approval of ruxolitinib, a JAK1/2 inhibitor, for treatment of patients aged ≥12 years with acute or chronic graft-versus-host disease (GvHD) who have inadequate response to corticosteroids or other systemic therapies.1 Previously, patients in Europe had no approved agents for steroid refractory (SR)-GvHD.
This announcement follows the positive opinion granted by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) for ruxolitinib in March 2022, which was based on the results of the phase III REACH2 (NCT02913261) and REACH3 (NCT03112603) trials.
In the REACH3 trial, ruxolitinib showed an overall response rate at Week 24 of 49.7%, compared with 25.6% for the best available therapy, in patients with SR-chronic GvHD. The best overall response rate achieved in this trial in the ruxolitinib group was 76.4% versus 60.4% in the best available therapy group. The New England Journal of Medicine published the results of the REACH3 trial in July 2021.2
Ruxolitinib has already been approved by the U.S. Food and Drug administration (FDA) for treating patients ≥12 years with SR-acute GvHD (in 2019) and also for those ≥12 years with chronic GvHD who have previously received 1–2 lines of therapy (in 2021).
FDA accepts a supplemental new drug application for ruxolitinib in steroid-refractory cGvHD
On February 22, 2021, the U.S. Food and Drug Administration (FDA) granted priority review to a supplemental new drug application (sNDA) for ruxolitinib for...
Editorial theme | Novel therapies for the treatment of GvHD
Currently, there are only two approved treatments for GvHD: ruxolitinib, indicated for steroid resistant (SR) aGvHD, and ibrutinib, used in patients with cGvHD who have failed one or more...
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