Health Canada has accepted for review the new drug submission seeking the approval of momelotinib in patients with myelofibrosis, according to a recent announcement from GlaxoSmithKline.1 The submission is based on findings from the phase 3 SIMPLIFY-1 (NCT01969838) and MOMENTUM (NCT04173494) trials.
Specifically, SIMPLIFY-1 data showed that of the 86 patients who received momelotinib, 31.4% (95% CI, 21.8%-42.3%) experienced a spleen volume response (SVR) reduction of 35% or higher vs 32.6% (95% CI, 23.4%-43.0%) of the 95 patients who received danazol.2
Moreover, findings from MOMENTUM indicated that a tumor symptom score (TSS) of at least 50% was observed in 25% of the 130 patients given momelotinib per the Myelofibrosis Symptom Assessment Form (MFSAF v4.0), representing a treatment difference of 16% (95% CI, 6%-26%; P < .01).2,3 The MFSAF v4.0 TSS change from baseline in the momelotinib and danazol arms were -9.4 and -3.1, respectively, equating to a difference of -6.2 (95% CI, -10 to -2.4; P = .001).