Tivozanib approved in the EU for advanced renal cell carcinoma
The European Commission has approved tivozanib (Fotivda) for the treatment of adults with advanced renal cell carcinoma within the EU.
Tivozanib is an orally active tyrosine kinase inhibitor that acts by blocking all three types of vascular endothelial growth factor receptor (VEGFR 1, 2 and 3), thus inhibiting angiogenesis and tumour growth. It has been licensed for the first-line treatment of adults with advanced renal cell carcinoma and for adults who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced renal cell carcinoma.
Tivozanib is available as 890µg and 1340µg hard capsules, and the dosage is 1340µg once daily for three weeks followed by a one-week rest period, over a treatment cycle of four weeks. The most common adverse effects are hypertension (nearly 48% of patients in clinical trials), dysphonia, fatigue and diarrhoea. The dosage can be reduced to 890µg once daily (or discontinued if necessary) if the higher dosage is not tolerated due to severe adverse effects, such as persistent hypertension despite antihypertensive therapy.
The approval follows a positive opinion from the CHMP in June this year. The committee considered clinical trial evidence from the phase 3 TIVO-1 trial, which studied 517 adult patients with advanced renal cell carcinoma. The trial showed that tivozanib was associated with a higher progression-free survival compared with the active comparator treatment sorafenib (11.9 vs 9.1 months; p=0.042).
Tivozanib is currently being appraised by NICE, with final guidance expected in December 2017.