FDA accepts filing for CYT 387 in myelofibrosis
GSK announced that the FDA accepted the New Drug Application (NDA) for CYT 387 (momelotinib), a potential new medicine with a proposed differentiated mechanism of action that may address the significant unmet medical needs of myelofibrosis patients with anaemia
The US FDA has assigned a Prescription Drug User Fee Act action date of 16 June 2023.
The NDA is based on the results from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary endpoints, including Total Symptom Score (TSS), Transfusion Independence (TI) rate and Splenic Response Rate (SRR). The primary analysis data from the MOMENTUM trial were recently presented at the 2022 American Society of Clinical Oncology Annual Meeting and the European Hematology Association 2022 Hybrid Congress.
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