Sierra Oncology Submits Application Seeking FDA Approval of Momelotinib to Treat Myelofibrosis

Sierra Oncology has submitted a new drug application to the Food and Drug Administration (FDA) for the JAK inhibitor momelotinib to treat myelofibrosis, a rare type of blood cancer.

According to the FDA, a new drug application is submitted by a pharmaceutical company when they are ready to formally seek approval from the agency to sell and market a new drug in the United States. In its application, the pharmaceutical company seeking a new drug approval must provide enough data to show that the drug is safe and effective in its targeted patient population. Moreover, the findings must show the benefits outweigh any potential risks from the drug.

The application for approval of momelotinib was submitted using data from multiple studies, including the phase 3 MOMENTUM trial.

In January, CURE® spoke with Dr. Srdan Verstovsek, a researcher on the MOMENTUM study and professor of medicine in the Department of Leukemia at The University of Texas MD Anderson Cancer Center in Houston, about the significant need of a drug like momelotinib for patients with myelofibrosis.

“Certainly if the drug is approved, as I would expect it to be in the very near future, momelotinib will be, by far, the No. 1 choice for therapy in the setting where it was tested,” Verstovsek said in an interview.

If the FDA accepts the new drug application, a date will be set by the agency to decide to approve momelotinib. Of note, the FDA can change the decision date, request further data before deciding or approve before the given date.

Sierra Oncology noted in a company-issued press release that if momelotinib is approved by the FDA that they anticipate making the drug available to patients with myelofibrosis in 2023.

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