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FDA approves momelotinib for the treatment of patients with anemic myelofibrosis

Sep 18, 2023
Learning objective: After reading this article, learners will be able to cite a new clinical development in 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.


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
(N = 130)

Danazol cohort
(N = 65)

Total Symptom Score reduction of ≥50%



Adverse events (Grade ≥3)









Acute kidney injury






*Data from Verstovsek, et al.2


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.

  1. GlaxoSmithKline.  Ojjaara (momelotinib) approved in the US as the first and only treatment indicated for myelofibrosis patients with anaemia.,for%20myelofibrosis%20patients%20with%20anaemia. Published September 15, 2023. Accessed September 18, 2023.
  2. 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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