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Ruxolitinib is approved by the European Commission for the treatment of patients with SR-GvHD

May 5, 2022
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Learning objective: After reading this article, learners will be able to cite a new clinical development in steroid-refractory GvHD.

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).

  1.  Novartis receives European Commission approval for Jakavi® to be the first post-steroid treatment for acute and chronic graft-versus-host disease. https://www.novartis.com/news/media-releases/novartis-receives-european-commission-approval-jakavi-be-first-post-steroid-treatment-acute-and-chronic-graft-versus-host-disease. Published May 5, 2022. Accessed May 5, 2022.
  2. Zeiser R, Polverelli N, Ram R, et al. Ruxolitinib for glucocorticoid-refractory chronic graft-versus-host disease. N Engl J Med. 2021;385(3):228-238. DOI: 1056/NEJMoa2033122