FDA Approves Fedratinib for Myelofibrosis

Based on efficacy data from the late-phase JAKARTA trial, in which 37% of patients treated with 400-mg fedratinib achieved a ≥ 35% reduction in spleen volume, compared with 1 of 96 patients who received placebo (< .0001), the US Food and Drug Administration approved fedratinib for the treatment of adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.

US Food and Drug Administration