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Regulatory approval of fedratinib 400\u2010mg daily was based on results of an updated analysis of the pivotal phase III, placebo\u2010controlled JAKARTA trial in patients with JAK\u2010inhibitor\u2010na\u00efve myelofibrosis. At week 24, spleen volume response rate was 47% and symptom response rate was 40% with fedratinib 400\u00a0mg, <jats:italic>versus<\/jats:italic> 1% and 9% respectively, with placebo. Common adverse events were diarrhoea, nausea, anaemia, and vomiting. No Wernicke encephalopathy occurred in patients receiving fedratinib 400\u00a0mg\/day. These updated data support use of first\u2010line fedratinib in patients with myelofibrosis.<\/jats:p>","DOI":"10.1111\/bjh.17727","type":"journal-article","created":{"date-parts":[[2021,7,31]],"date-time":"2021-07-31T04:51:07Z","timestamp":1627707067000},"page":"244-248","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":69,"title":["Updated results of the placebo\u2010controlled, phase III JAKARTA trial of fedratinib in patients with intermediate\u20102 or high\u2010risk myelofibrosis"],"prefix":"10.1111","volume":"195","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9084-4148","authenticated-orcid":false,"given":"Animesh","family":"Pardanani","sequence":"first","affiliation":[{"name":"Mayo Clinic of Rochester Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4605-3821","authenticated-orcid":false,"given":"Ayalew","family":"Tefferi","sequence":"additional","affiliation":[{"name":"Mayo Clinic of Rochester Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tam\u00e1s","family":"Masszi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Haematology Semmelweis University Budapest Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Mishchenko","sequence":"additional","affiliation":[{"name":"Lady Davis Medical Center Haifa Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Drummond","sequence":"additional","affiliation":[{"name":"Beatson Cancer Centre University of Glasgow Glasgow UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Jourdan","sequence":"additional","affiliation":[{"name":"CHU Caremeau Nimes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Vannucchi","sequence":"additional","affiliation":[{"name":"University of Florence AOU Careggi Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mindaugas","family":"Jurgutis","sequence":"additional","affiliation":[{"name":"Klaipeda Jurininku Hospital Klaipeda Lithuania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent","family":"Ribrag","sequence":"additional","affiliation":[{"name":"Institut Gustave Roussy Villejuif France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Rambaldi","sequence":"additional","affiliation":[{"name":"Department of Oncology and Hematology University of Milan Milan Italy"},{"name":"Azienda Socio Sanitaria Territorial Papa Giovanni XXIII Bergamo Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liang Piu","family":"Koh","sequence":"additional","affiliation":[{"name":"National University Hospital Singapore Singapore Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shelonitda","family":"Rose","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Princeton NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Zhang","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Princeton NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire","family":"Harrison","sequence":"additional","affiliation":[{"name":"Guy's and St Thomas' Hospital London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,7,30]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/leu.2013.119"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2015.1590"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2018.00287"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-14-0736"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.25777"},{"key":"e_1_2_8_7_1","unstructured":"INREBIC\u00ae (fedratinib) prescribing information. 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