Fedratinib

Fedratinib (Inrebic, Bristol Myers Squibb Pharma EEIG) has 1 EU-approved indication in 1 tumour type.
Approved indications of Fedratinib
Biomarker requirementRegimenSettingConditions
Myeloproliferative neoplasms1
None
Monotherapy
Any line
Myelofibrosis only; Janus Associated Kinase (JAK) inhibitor naïve or treated with ruxolitinib; Disease-related splenomegaly or symptoms
Full text of section 4.1 (therapeutic indications)

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.

Label history

10 changes to the Inrebic label since 2021, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes