Abstract
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.
Keywords:
JAK inhibitor; fedratinib; myelofibrosis.
© 2021 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.
Publication types
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Clinical Trial, Phase III
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Randomized Controlled Trial
MeSH terms
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Administration, Oral
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Adult
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Aged
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Aged, 80 and over
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Case-Control Studies
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Follow-Up Studies
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Humans
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Janus Kinase 2 / antagonists & inhibitors*
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Janus Kinase Inhibitors / administration & dosage
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Janus Kinase Inhibitors / adverse effects
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Janus Kinase Inhibitors / pharmacology
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Janus Kinase Inhibitors / therapeutic use*
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Middle Aged
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Placebos / administration & dosage
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Primary Myelofibrosis / complications
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Primary Myelofibrosis / diagnosis
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Primary Myelofibrosis / drug therapy*
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Pyrrolidines / administration & dosage
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Pyrrolidines / adverse effects
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Pyrrolidines / pharmacology
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Pyrrolidines / therapeutic use*
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Safety
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Spleen / drug effects
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Splenomegaly / drug therapy
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Sulfonamides / administration & dosage
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Sulfonamides / adverse effects
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Sulfonamides / pharmacology
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Sulfonamides / therapeutic use*
Substances
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Janus Kinase Inhibitors
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Placebos
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Pyrrolidines
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Sulfonamides
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fedratinib
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JAK2 protein, human
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Janus Kinase 2