Sierra Oncology (NASDAQ:SRRA) received FDA fast track designation for momelotinib for the treatment of myelofibrosis.
Momelotinib is designed to improve anemia that frequently occurs in myelofibrosis, or cancer of the bone marrow.
“These patients typically suffer from uncontrolled constitutional symptoms, progressively worsening anemia [that often results] in transfusion dependency, and enlarged spleens,” Dr. Barbara Klencke, Sierra Oncology’s chief development officer, said in a statement.
Sierra plans to launch a Phase 3 study of momelotinib in the fourth quarter of 2019.
The trial will enroll some 180 myelofibrosis patients who are symptomatic and anemic and have been previously treated with a JAK inhibitor. The trial’s primary endpoint is the total symptom score response rate of momelotinib compared to danazol, a treatment comparator, at week 24.
“Fast track also recognizes the absence of FDA-approved treatments for these patients and that momelotinib has the potential to address their unmet needs,” she added.
