The European Commission ( EC ) has approved Fotivda ( Tivozanib ) for the treatment of adult patients with advanced renal cell carcinoma ( RCC ) in the European Union plus Norway and Iceland.
Tivozanib is indicated for the first line treatment of adult patients with advanced renal cell carcinoma and for adult patients who are vascular endothelial growth factor receptor ( VEGFR ) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced renal cell carcinoma.
Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor ( VEGFR-TKI ).
It is a long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.
The approval from the EC follows the recommendation from the Committee for Medical Products for Human Use ( CHMP ).
The decision was primarily based on data from a global, open-label, randomized, multi-center phase 3 trial ( TIVO-1 ), which evaluated the efficacy and tolerability of Tivozanib compared to a currently available comparator VEGFR-TKI treatment, Sorafenib ( Nexavar ), in 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 =.042 ] and 12.7 vs. 9.1 months in treatment naïve patients [ HR=0.756; 95% CI, 0.580 to 0.985; P =.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 diarrhea ( 23% vs 33% ) and hand-foot syndrome ( 14% vs 54% ).
Renal cell carcinoma is the most common form of kidney cancer, which accounts for an estimated 49,000 deaths in Europe each year. It is expected to be one of the fastest increasing cancers over the next ten years.
VEGF tyrosine Kinase inhibitors are the standard of care treatment for advanced renal cell carcinoma in Europe, however, patients on current treatments can often experience significant side effects. ( Xagena )
Source: Aveo Oncology, 2017