Nina Mojas The Ministry of Health, Labour, and Welfare in Japan has approved momelotinib (Omjjara) for use in patients with myelofibrosis, according to an announcement from GlaxoSmithKline. 1 The regulatory decision is supported by data from the phase 3 MOMENTUM (NCT04173494) and SIMPLIFY-1 (NCT01969838) trials. In MOMENTUM, 25% of patients who received momelotinib (n = 130) experienced a Myelofibrosis Symptom Assessment Form (MFSAF v4.
0) tumor symptom score (TSS) reduction of 50% or higher at week 24 vs baseline compared with 9% of those who were given danazol; this translated to a difference of 16% between the arms, meeting the primary end point of the study (95% CI, 6%-26%; P < .01). 2 Additionally, 22% of patients in the momelotinib arm experienced a spleen volume response (SVR) reduction of 35% or more vs 3% of those in the danazol arm, translating to a difference of 18% between the arms (95% CI, 10%-27%; P = .
001). Lastly, 30% vs 20% of patients in the momelotinib and danazol arms, respectively, achieved transfusion independence (TI), which translated to a noninferiority treatment difference of 14% (95% CI, 2%-25%; P = .023).
In SIMPLIFY-1, momelotinib (n = 215) proved noninferior to ruxolitinib (Jakafi; n = 217) with regard to achievement of a SVR reduction of 35% or higher, with a 9% difference between the arms (95% CI, 2%-16%).1 Treatment with momelotinib also resulted in an improved TI rate vs ruxolitinib, at 66.5% and 49.
3%, respectively, translating to a differenc.
