European Commission licences EUSA’s advanced RCC treatment fotivda

Jazz Pharmaceuticals subsidiary EUSA Pharma’s fotivda (tivozanib) has been licensed by the European Commission (EC) for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

Fotivda is an oral, once-daily, potent selective vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKI), which help reduce the supply of blood to the tumour.

Authorised for use in the European Union (EU), including Norway and Iceland, tivozanib is also indicated for adults who are VEGFR and mechanistic target of rapamycin (mTOR) pathway inhibitor-naïve, following disease progression after one prior treatment with cytokine therapy for advanced RCC.

The EC licence for the EUSA Pharma treatment follows the recommendation from the Committee for Medicinal Products for Human Use (CHMP).

The decision was mainly based on the study results from the global, open-label, randomised, multi-centre Phase III trial TiVO-1.

Involving 517 patients with advanced RCC, the trial studied the efficacy and tolerability of tivozanib compared to a currently available comparator VEGFR-TKI treatment, sorafenib.

EUSA Pharma medical director Dr Jon Morgan said: "Today’s licensing of tivozanib by the EC is an important step in expanding treatment options for patients with advanced RCC, where, despite advancements in therapy, survival rates in advanced disease remain low.

"The licensing of tivozanib is supported by results from the TiVO-1 pivotal study, which demonstrated efficacy of tivozanib as a first-line treatment."

In December 2015, EUSA Pharma entered a licence agreement with Aveo Pharmaceuticals, under which the company has exclusive marketing rights to tivozanib for advanced RCC in Europe, as well as other territories outside North America, including South America and South Africa.