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      FDA Approval Summary: Ruxolitinib for Treatment of Steroid‐Refractory Acute Graft‐Versus‐Host Disease

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          Abstract

          On May 24, 2019, the Food and Drug Administration approved ruxolitinib for steroid‐refractory acute graft‐versus‐host disease (SR‐aGVHD) in adult and pediatric patients 12 years and older. Approval was based on Study INCB 18424‐271 (REACH‐1; NCT02953678), an open‐label, single‐arm, multicenter trial that included 49 patients with grades 2–4 SR‐aGVHD occurring after allogeneic hematopoietic stem cell transplantation. Ruxolitinib was administered at 5 mg twice daily, with dose increases to 10 mg twice daily permitted after 3 days in the absence of toxicity. The Day‐28 overall response rate was 57.1% (95% confidence interval [CI]: 42.2–71.2). The median duration of response was 0.5 months (95% CI: 0.3–2.7), and the median time from Day‐28 response to either death or need for new therapy for acute GVHD was 5.7 months (95% CI: 2.2 to not estimable). Common adverse reactions included anemia, thrombocytopenia, neutropenia, infections, edema, bleeding, and elevated transaminases. Ruxolitinib is the first drug approved for treatment of SR‐aGVHD. Ruxolitinib is the first Food and Drug Administration–approved treatment for steroid‐refractory acute graft‐versus‐host disease in adult and pediatric patients 12 years and older. Its approval provides a treatment option for the 60% of those patients who do not respond to steroid therapy. Ruxolitinib is the first FDA‐approved treatment for steroid‐refractory acute graft‐versus‐host disease. This article provides a summary of the FDA review of ruxolitinib, based on the REACH‐1 Study.

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          Author and article information

          Journal
          The Oncologist
          The Oncol
          Wiley
          1083-7159
          1549-490X
          February 2020
          October 22 2019
          February 2020
          : 25
          : 2
          Affiliations
          [1 ]Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USA
          [2 ]Oncology Center of Excellence, U.S. Food and Drug Administration Silver Spring Maryland USA
          Article
          10.1634/theoncologist.2019-0627
          7011641
          32043777
          c5d3e352-3ec2-418d-be61-3abe96b73ade
          © 2020

          http://onlinelibrary.wiley.com/termsAndConditions#vor

          http://doi.wiley.com/10.1002/tdm_license_1.1

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