Dr. Rossetti on the Fast Track Designation of Momelotinib in Myelofibrosis

James M. Rossetti, DO, hematologist, UPMC Hillman Cancer Center, discusses the FDA’s decision to grant momelotinib a fast track designation for use in patients with intermediate- or high-risk myelofibrosis who previously received a JAK inhibitor.

One of the concerns with agents such as momelotinib is dismissing them too early, says Rossetti. Sometimes, agents are dismissed due to the design of the trial, but other times the dismissal is due to selecting the wrong patient population, explains Rossetti.

This group of patients who received momelotinib in the phase III MOMENTUM trial is difficult to study because the they are heterogeneous, making analysis more challenging. Long-term follow-up becomes the key, according to Rossetti; however, the responsible use of these agents that get to market is going to make a difference in the long-run because it is very hard to prove long-term benefit in small clinical trials, Rossetti concludes.