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.

Updated results of the placebo-controlled, phase III JAKARTA trial of fedratinib in patients with intermediate-2 or high-risk myelofibrosis / Pardanani A.; Tefferi A.; Masszi T.; Mishchenko E.; Drummond M.; Jourdan E.; Vannucchi A.; Jurgutis M.; Ribrag V.; Rambaldi A.; Koh L.P.; Rose S.; Zhang J.; Harrison C.. - In: BRITISH JOURNAL OF HAEMATOLOGY. - ISSN 0007-1048. - ELETTRONICO. - 195:(2021), pp. 244-248. [10.1111/bjh.17727]

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

Vannucchi A.;Zhang J.;
2021

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.
2021
195
244
248
Pardanani A.; Tefferi A.; Masszi T.; Mishchenko E.; Drummond M.; Jourdan E.; Vannucchi A.; Jurgutis M.; Ribrag V.; Rambaldi A.; Koh L.P.; Rose S.; Zhang J.; Harrison C.
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Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/1257172
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