Updated results of the placebo‐controlled, phase III JAKARTA trial of fedratinib in patients with intermediate‐2 or high‐risk myelofibrosis. (30th July 2021)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: British journal of haematology. Volume 195:Number 2(2021)
• Page Start: 244
• Page End: 248
• Publication Date: 2021-07-30
• Subjects: myelofibrosis -- fedratinib -- JAK inhibitor; Hematology -- Periodicals; Blood -- Diseases -- Periodicals; 616.15
• DOI: 10.1111/bjh.17727
• Languages: English
• ISSNs: 0007-1048

Abstract

Summary: 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.