Updated results of the placebo‐controlled, phase III JAKARTA trial of fedratinib in patients with intermediate‐2 or high‐risk myelofibrosis

Fedratinib, an oral Janus kinase‐2 (JAK2) inhibitor, reduces splenomegaly and improves symptom burden in patients with myelofibrosis. Regulatory approval of fedratinib 400‐mg daily was based on results of an updated analysis of the pivotal phase III, placebo‐controlled JAKARTA trial in patients with...

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Detalles Bibliográficos
Autores principales: Pardanani, Animesh, Tefferi, Ayalew, Masszi, Tamás, Mishchenko, Elena, Drummond, Mark, Jourdan, Eric, Vannucchi, Alessandro, Jurgutis, Mindaugas, Ribrag, Vincent, Rambaldi, Alessandro, Koh, Liang Piu, Rose, Shelonitda, Zhang, Jun, Harrison, Claire
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Haematological malignancy–Clinical
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9292894/
https://www.ncbi.nlm.nih.gov/pubmed/34331348
http://dx.doi.org/10.1111/bjh.17727
Descripción
Sumario:Fedratinib, an oral Janus kinase‐2 (JAK2) inhibitor, reduces splenomegaly and improves symptom burden in patients with myelofibrosis. Regulatory approval of fedratinib 400‐mg daily was based on results of an updated analysis of the pivotal phase III, placebo‐controlled JAKARTA trial in patients with JAK‐inhibitor‐naïve myelofibrosis. At week 24, spleen volume response rate was 47% and symptom response rate was 40% with fedratinib 400 mg, versus 1% and 9% respectively, with placebo. Common adverse events were diarrhoea, nausea, anaemia, and vomiting. No Wernicke encephalopathy occurred in patients receiving fedratinib 400 mg/day. These updated data support use of first‐line fedratinib in patients with myelofibrosis.

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