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Sierra Oncology Submits NDA For Momelotinib
Sierra Oncology is seeking approval of momelotinib as a treatment for patients with myelofibrosis, a bone marrow cancer.
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.
Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
November 16th 2022In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
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FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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