Fast track designation to momelotinib for myelofibrosis

August 6, 2019 0 By FM

Momelotinib has been granted Fast Track designation for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor.

Momelotinib is a potent, selective and orally bioavailable JAK1, JAK2 & ACVR1 inhibitor with a differentiated therapeutic profile in myelofibrosis

A randomized, double-blind, phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anaemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor Therapy.

Sierra plans to launch the MOMENTUM phase 3 clinical trial in Q4 2019. The randomized double-blind trial is designed to enroll 180 myelofibrosis patients who are symptomatic and anaemic and have been treated previously with a JAK inhibitor.

Patients will be randomized 2:1 to receive either momelotinib or danazol.  Danazol has been selected as an appropriate treatment comparator given its use to ameliorate anaemia in myelofibrosis patients, as recommended by NCCN and ESMO guidelines. After 24 weeks of treatment, patients on danazol will be allowed to crossover to receive momelotinib.