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...

Descripción completa

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
_version_ 1784749486349746176
author 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
author_facet 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
author_sort Pardanani, Animesh
collection PubMed
description 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.
format Online
Article
Text
id pubmed-9292894
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-92928942022-07-20 Updated results of the placebo‐controlled, phase III JAKARTA trial of fedratinib in patients with intermediate‐2 or high‐risk myelofibrosis 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 Br J Haematol Haematological malignancy–Clinical 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. John Wiley and Sons Inc. 2021-07-30 2021-10 /pmc/articles/PMC9292894/ /pubmed/34331348 http://dx.doi.org/10.1111/bjh.17727 Text en © 2021 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Haematological malignancy–Clinical
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
Updated results of the placebo‐controlled, phase III JAKARTA trial of fedratinib in patients with intermediate‐2 or high‐risk myelofibrosis
title Updated results of the placebo‐controlled, phase III JAKARTA trial of fedratinib in patients with intermediate‐2 or high‐risk myelofibrosis
title_full Updated results of the placebo‐controlled, phase III JAKARTA trial of fedratinib in patients with intermediate‐2 or high‐risk myelofibrosis
title_fullStr Updated results of the placebo‐controlled, phase III JAKARTA trial of fedratinib in patients with intermediate‐2 or high‐risk myelofibrosis
title_full_unstemmed Updated results of the placebo‐controlled, phase III JAKARTA trial of fedratinib in patients with intermediate‐2 or high‐risk myelofibrosis
title_short Updated results of the placebo‐controlled, phase III JAKARTA trial of fedratinib in patients with intermediate‐2 or high‐risk myelofibrosis
title_sort updated results of the placebo‐controlled, phase iii jakarta trial of fedratinib in patients with intermediate‐2 or high‐risk myelofibrosis
topic Haematological malignancy–Clinical
url 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
work_keys_str_mv AT pardananianimesh updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis
AT tefferiayalew updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis
AT masszitamas updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis
AT mishchenkoelena updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis
AT drummondmark updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis
AT jourdaneric updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis
AT vannucchialessandro updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis
AT jurgutismindaugas updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis
AT ribragvincent updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis
AT rambaldialessandro updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis
AT kohliangpiu updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis
AT roseshelonitda updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis
AT zhangjun updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis
AT harrisonclaire updatedresultsoftheplacebocontrolledphaseiiijakartatrialoffedratinibinpatientswithintermediate2orhighriskmyelofibrosis

Ejemplares similares