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FDA approves momelotinib for the treatment of patients with anemic myelofibrosis
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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.
MOMENTUM2
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 |
||
SIMPLIFY-11
In the population of patients with anemia and MF from SIMPLIFY-1:
- Both the momelotinib and ruxolitinib cohorts had comparable spleen volume reduction, but a lower symptom response rate was observed with momelotinib
- The most commonly occurring adverse events in the momelotinib cohort included: thrombocytopenia, hemorrhage, bacterial infection, fatigue, dizziness, diarrhea, and nausea.
- GlaxoSmithKline. Ojjaara (momelotinib) approved in the US as the first and only treatment indicated for myelofibrosis patients with anaemia. https://www.gsk.com/en-gb/media/press-releases/ojjaara-momelotinib-approved-in-the-us-as-the-first-and-only-treatment-indicated-for-myelofibrosis-patients-with-anaemia/#:~:text=Ojjaara%20(momelotinib)%20approved%20in%20the,for%20myelofibrosis%20patients%20with%20anaemia. Published September 15, 2023. Accessed September 18, 2023.
- Verstovsek S, Gerds A, Vannucchi A, et al. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): Results from an international, double-blind, randomised, controlled, phase 3 study. 2023;401(10373):269-280. DOI: 10.1016/S0140-6736(22)02036-0.
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