Tivozanib

Tivozanib (Fotivda, Recordati Netherlands B.V.) has 2 EU-approved indications in 1 tumour type.
Approved indications of Tivozanib
Biomarker requirementRegimenSettingConditions
Renal cell carcinoma2
None
Monotherapy
1L
advanced
None
None
Monotherapy
2L
advanced
After one prior treatment with cytokine therapy; VEGFR and mTOR pathway inhibitor-naïve
Full text of section 4.1 (therapeutic indications)

Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.

Label history

There is no record of changes to the Fotivda label that oncolabels can read yet. EMA publishes it some months after the first approval.