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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Bibliografski detalji
Izdano u:Oncologist
Glavni autori: 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
Jezik:Inglês
Izdano: John Wiley & Sons, Inc. 2019
Teme:
Regulatory Issues: FDA
Online pristup: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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