All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the MPN Advocates Network.
The MPN Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy
The MPN Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the MPN Hub cannot guarantee the accuracy of translated content. The MPN Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
FDA approves momelotinib for the treatment of patients with anemic myelofibrosis
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.
Related articles
Newsletter
Subscribe to get the best content related to MPN delivered to your inbox