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On September 15, 2023, the U.S. Food and Drug Administration granted approval to momelotinib, an oral inhibitor of Janus kinase (JAK) 1, JAK2, and activin A type 1 receptor (ACVR1), for the treatment of patients with anemic myelofibrosis (MF).1 This approval includes patients with primary and secondary MF, regardless of prior treatment, including those with hemoglobin levels <10 g/dL.2
The decision was based on data from MOMENTUM and a subset of patients with anemia from SIMPLIFY-1.
A summary of the pivotal data from MOMENTUM is shown in Table 1.
Table 1. Key safety and efficacy data from MOMENTUM*
Outcome measure (%, unless otherwise stated) |
Momelotinib cohort |
Danazol cohort |
---|---|---|
Total Symptom Score reduction of ≥50% |
25 |
9 |
Adverse events (Grade ≥3) |
|
|
Anemia |
61 |
75 |
Thrombocytopenia |
28 |
26 |
Acute kidney injury |
3 |
9 |
Pneumonia |
2 |
9 |
*Data from Verstovsek, et al.2 |
In the population of patients with anemia and MF from SIMPLIFY-1:
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