CYT 387 filed with FDA for myelofibrosis.- Sierra Oncology
Sierra Oncology announced the company has submitted a New Drug Application (NDA) to the FDA for CYT 387 (momelotinib), an ACVR1 / ALK2, JAK1 and JAK2 inhibitor in development for the treatment of myelofibrosis.
The NDA submission is based on the results from several Phase II and Phase III 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.
MOMENTUM is a global, randomized, double-blind Phase III clinical trial of momelotinib versus danazol in patients with myelofibrosis who were symptomatic and anemic, and had been previously treated with an FDA-approved JAK inhibitor. The study 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 splenomegaly (enlarged spleen). Results from the MOMENTUM study were presented at the 2022 Annual Meeting of the American Society of Clinical Oncology.
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