Myeloproliferative neoplasms

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

Disease

Line of therapy

Approved indications, Myeloproliferative neoplasms
DrugBiomarker requirementRegimenSettingConditions
FIP1L1::PDGFRA fusion1
Imatinib
Glivec
FIP1L1-PDGFRalpha rearrangement
Monotherapy
Any line
advanced
HES or CEL only
No biomarker required6
Ruxolitinib
Jakavi, Ruxolitinib Viatris
None
Monotherapy
2L
Polycythaemia vera only; Resistant to or intolerant of hydroxyurea
Fedratinib
Inrebic
None
Monotherapy
Any line
Myelofibrosis only; Janus Associated Kinase (JAK) inhibitor naïve or treated with ruxolitinib; Disease-related splenomegaly or symptoms
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
None
Monotherapy
Any line
Polycythaemia vera or essential thrombocythaemia only
None
Monotherapy
Any line
Polycythaemia vera only; Without symptomatic splenomegaly
Ruxolitinib
Jakavi, Ruxolitinib Viatris
None
Monotherapy
Any line
Myelofibrosis only; Disease-related splenomegaly or symptoms

Biomarkers in myeloproliferative neoplasms

Label wording7

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Imatinib (Glivec)
    adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
  2. Ropeginterferon alfa-2b (Besremi)
    Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
  3. Peginterferon alfa-2a (Pegasys)
    Pegasys is indicated as monotherapy in adults for the treatment of polycythaemia vera.
  4. Fedratinib (Inrebic)
    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.
  5. Momelotinib (Omjjara)
    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.
  6. Ruxolitinib (Jakavi, Ruxolitinib Viatris)
    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.
  7. Ruxolitinib (Jakavi, Ruxolitinib Viatris)
    Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.