Ruxolitinib

Ruxolitinib (Jakavi, Ruxolitinib Viatris) has 2 EU-approved indications in 1 tumour type.
Approved indications of Ruxolitinib
Biomarker requirementRegimenSettingConditions
Myeloproliferative neoplasms2
None
Monotherapy
2L
Polycythaemia vera only; Resistant to or intolerant of hydroxyurea
None
Monotherapy
Any line
Myelofibrosis only; Disease-related splenomegaly or symptoms
Full text of section 4.1 (therapeutic indications)
Ruxolitinib Viatris

Myelofibrosis (MF) Ruxolitinib Viatris 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. Polycythaemia vera (PV) Ruxolitinib Viatris is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea. Graft versus host disease (GvHD) Acute GvHD Ruxolitinib Viatris is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1). Chronic GvHD Ruxolitinib Viatris is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).

Jakavi

Myelofibrosis (MF) 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. Polycythaemia vera (PV) Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea. Graft versus host disease (GvHD) Acute GvHD Jakavi is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1). Chronic GvHD Jakavi is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).

Label history

34 changes to the Jakavi label since 2013, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Product

Changes