FDA Grants Fast Track to Momelotinib for Intermediate/High-Risk Myelofibrosis

The Food and Drug Administration (FDA) granted a fast track designation to momelotinib for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor, according to Sierra Oncology — the drug’s manufacturer.

"We are very pleased that momelotinib has been granted Fast Track designation by the FDA, which further reflects the collaborative and constructive dialogue we have had with the Agency concerning the advancement of momelotinib towards potential registration," Dr. Nick Glover, president & CEO of Sierra Oncology said in a press release.

The JAK1, JAK2 and ACVR1 inhibitor will be evaluated in the randomized, double-blind phase 3 study — expected later this year – and compared with danazol in 180 patients with myelofibrosis who are symptomatic and anemic and have been treated previously with a JAK inhibitor.

Fast track designations can be based on clinical or nonclinical data, and they speed up the development and review of drugs to treat serious conditions. This is based on whether the drug will have an impact on factors like survival, day-to-day functioning or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. After a drug is given a fast track designation, the drug manufacturer will have more frequent interactions with the FDA and may be given a rolling review.

"Fast Track designation for momelotinib highlights the serious and significant unmet needs of patients with myelofibrosis who have previously received a JAK inhibitor. These patients typically suffer from uncontrolled constitutional symptoms, progressively worsening anemia often resulting in transfusion dependency, and enlarged spleens. Fast Track also recognizes the absence of FDA-approved treatments for these patients and that momelotinib has the potential to address their unmet needs," Dr. Barbara Klencke, chief development officer of Sierra Oncology, said in the release. "We look forward to continuing to work closely with the FDA as we launch and conduct the MOMENTUM phase 3 trial of momelotinib, with the goal of bringing this important therapy to patients expeditiously."