# Myeloproliferative neoplasms

The EU has approved 7 indications of 6 drugs in myeloproliferative neoplasms. 1 of them needs a biomarker result: FIP1L1::PDGFRA (1).

## Approved indications

### FIP1L1::PDGFRA fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Imatinib](https://oncolabels.com/drugs/imatinib) (Glivec) | FIP1L1-PDGFRalpha rearrangement | Monotherapy | Advanced | HES or CEL only |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Ruxolitinib](https://oncolabels.com/drugs/ruxolitinib) (Jakavi, Ruxolitinib Viatris) | None | Monotherapy | 2nd line | Polycythaemia vera only; Resistant to or intolerant of hydroxyurea |
| [Fedratinib](https://oncolabels.com/drugs/fedratinib) (Inrebic) | None | Monotherapy | Any line | Myelofibrosis only; Janus Associated Kinase (JAK) inhibitor naïve or treated with ruxolitinib; Disease-related splenomegaly or symptoms |
| [Momelotinib](https://oncolabels.com/drugs/momelotinib) (Omjjara) | 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 |
| [Peginterferon alfa-2a](https://oncolabels.com/drugs/peginterferon-alfa-2a) (Pegasys) | None | Monotherapy | Any line | Polycythaemia vera or essential thrombocythaemia only |
| [Ropeginterferon alfa-2b](https://oncolabels.com/drugs/ropeginterferon-alfa-2b) (Besremi) | None | Monotherapy | Any line | Polycythaemia vera only; Without symptomatic splenomegaly |
| [Ruxolitinib](https://oncolabels.com/drugs/ruxolitinib) (Jakavi, Ruxolitinib Viatris) | None | Monotherapy | Any line | Myelofibrosis only; Disease-related splenomegaly or symptoms |

## Label wording

- **Imatinib** (Glivec), Myeloid/lymphoid neoplasms with eosinophilia and TK fusions, advanced: “adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Ropeginterferon alfa-2b** (Besremi), Myeloproliferative neoplasms, any line: “Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/besremi-epar-product-information_en.pdf)
- **Peginterferon alfa-2a** (Pegasys), Myeloproliferative neoplasms, any line: “Pegasys is indicated as monotherapy in adults for the treatment of polycythaemia vera.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/pegasys-epar-product-information_en.pdf)
- **Fedratinib** (Inrebic), Myeloproliferative neoplasms, any line: “Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/inrebic-epar-product-information_en.pdf)
- **Momelotinib** (Omjjara), Myeloproliferative neoplasms, any line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/omjjara-epar-product-information_en.pdf)
- **Ruxolitinib** (Jakavi, Ruxolitinib Viatris), Myeloproliferative neoplasms, any line: “Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/jakavi-epar-product-information_en.pdf)
- **Ruxolitinib** (Jakavi, Ruxolitinib Viatris), Myeloproliferative neoplasms, 2nd line: “Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/jakavi-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/tumours/myeloproliferative-neoplasms