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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Bibliografiset tiedot
Julkaisussa:Oncologist
Päätekijät: 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
Aineistotyyppi: Artigo
Kieli:Inglês
Julkaistu: John Wiley & Sons, Inc. 2019
Aiheet:
Regulatory Issues: FDA
Linkit: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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