Sierra Oncology Announces Submission of New Drug Application for Momelotinib to US Food & Drug Administration
The NDA submission is based on the results from several Phase 2 and Phase 3 studies, including the recently completed MOMENTUM study.
- 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.
- Sierra Oncology is a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer.