Sierra Oncology Submits NDA For Momelotinib

Sierra Oncology has submitted a new drug application (NDA) to the FDA for momelotinib, an ACVR1/ALK2, JAK1 and JAK2 inhibitor in development for the treatment of myelofibrosis, a bone marrow cancer.

The NDA submission is based on the results from several phase 2 and phase 3 studies, including the recently completed MOMENTUM study. As with all new drug applications, the company expects the FDA to respond as to whether this submission is accepted within 60 days. Assuming the submission is accepted and a subsequent approval is granted, commercial launch of momelotinib is anticipated in 2023.

The phase 3 clinical trial of momelotinib versus danazol was designed to evaluate the safety and efficacy of momelotinib for the treatment and reduction of the key hallmarks of disease: symptoms, blood transfusions (due to anemia) and enlarged spleen. Results from the MOMENTUM study were presented at the 2022 Annual Meeting of the American Society of Clinical Oncology.