The European Commission ( EC ) has licensed Fotivda ( Tivozanib ) for the management of adult patients with advanced renal cell carcinoma ( RCC ) in the European Union plus Norway and Iceland.
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.

Tivozanib is an oral, once-daily, potent selective vascular endothelial growth factor receptor tyrosine kinase inhibitors ( VEGFR-TKI ).

The authorisation from the EC follows the recommendation from the Committee for Medicinal Products for Human Use ( CHMP ).
The decision was primarily based on data from global, open-label, randomised, multi-centre phase III trial ( TiVO-1 ) which evaluated the efficacy and tolerability of Tivozanib compared to a currently available comparator VEGFR-TKI treatment ( Sorafenib ) in the treatment of 517 patients with advanced renal cell carcinoma.
Patients treated with Tivozanib experienced superior progression-free survival ( PFS ) ( 11.9 vs. 9.1 months in the overall population [ hazard ratio, HR, 0.797; 95% CI, 0.639 to 0.993; P =0.042 ] and 12.7 vs. 9.1 months in treatment naïve patients [ HR, 0.756; 95% CI, 0.580 to 0.985; P =0.037 ] ) versus Sorafenib.
There was also an improved side effect profile with Tivozanib, with only 14% ( versus 43% with Sorafenib ) requiring a dose reduction due to adverse events.
In addition, fewer people on Tivozanib experienced burdensome side effects, such as diarrhoea ( 23% vs 33% ), and hand-foot syndrome ( 14% vs 54% ).

Kidney cancer is the seventh most common cancer in Europe, with more than 115,000 new cases diagnosed each year.
Renal cell carcinoma is the most common form of kidney cancer, accounting for 80% of cases and there are an estimated 49,000 deaths from kidney cancer each year in Europe.
Kidney cancer is expected to be one of the fastest increasing cancers over the next ten years, as a result of Europe’s ageing population, with smoking and a rise in obesity also playing a part.

An over-expression of VEGF protein, and a resulting increase in tumour blood supply ( angiogenesis ), is a common feature of renal cell carcinoma.
VEGFR-TKIs reduce the supply of blood to the tumour and are the recommended first-line treatment for advanced renal cell carcinoma in European Union, however, patients often experience significant side effects, including fatigue, diarrhoea, and hand-foot syndrome. ( Xagena_2017 )

Source: EUSA Pharma, 2017

Xagena_Medicina_2017