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

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...

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Bibliographische Detailangaben
Veröffentlicht in:Oncologist
Hauptverfasser: Przepiorka, Donna, Luo, Lola, Subramaniam, Sriram, Qiu, Junshan, Gudi, Ramadevi, Cunningham, Lea C., Nie, Lei, Leong, Ruby, Ma, Lian, Sheth, Christopher, Deisseroth, Albert, Goldberg, Kirsten B., Blumenthal, Gideon M., Pazdur, Richard
Format: Artigo
Sprache:Inglês
Veröffentlicht: John Wiley & Sons, Inc. 2019
Schlagworte:
Regulatory Issues: FDA
Online Zugang:https://ncbi.nlm.nih.gov/pmc/articles/PMC7011641/
https://ncbi.nlm.nih.gov/pubmed/32043777
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2019-0627
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