Momelotinib
Momelotinib (Omjjara, GlaxoSmithKline Trading Services Limited) has 1 EU-approved indication in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Myeloproliferative neoplasms1 | |||
None | Monotherapy | Any line | Myelofibrosis only; Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib; Moderate to severe anaemia; disease-related splenomegaly or symptoms |
Full text of section 4.1 (therapeutic indications)
Omjjara is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
Label history
2 changes to the Omjjara label since 2025, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes