EUSA announced the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Fotivda (tivozanib) for the management of adult patients with advanced renal cell carcinoma (RCC). EUSA's marketing authorization application included data from the TiVO-1 pivotal study, which included over 500 patients with advanced RCC. Following the positive CHMP opinion, the European Commission will now issue a formal decision on approval, and if granted, tivozanib will be indicated for use in the 28 countries of the European Union plus Norway and Iceland, for the first-line treatment of adult patients with advanced 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.
This positive CHMP opinion follows the European Commission's recent expedited approval of EUSA's dinutuximab beta is the only immunotherapy indicated for the treatment of high risk neuroblastoma in Europe. The approval followed a positive CHMP opinion issued at the end of March 2017.
"Today's opinion by the CHMP to recommend marketing authorization of tivozanib in the EU is an important step in expanding treatment options for patients with advanced renal cell carcinoma, where, despite advancements in therapy, survival rates in advanced disease remain low and existing treatments can be associated with therapy-limiting toxicities," said Dr Jon Morgan, Medical Director, EUSA Pharma. "The opinion is supported by robust and consistent results from the TiVO-1 pivotal study which demonstrated compelling efficacy of tivozanib as a first-line treatment, and importantly for this class of agents, a highly favorable and advantageous tolerability profile."
Kidney cancer is responsible for 5% of malignancies in men and 3% in women, making it the 7th and 10th most common type of cancer respectively. Of these kidney cancers, approximately 80% are renal cell carcinoma (RCC). Known risk factors for RCC include cigarette smoking, obesity and hypertension.
Tivozanib is an oral, once-daily, vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor. It is a potent, selective and 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. Tivozanib has been investigated in several tumor types, including renal cell, colorectal and breast cancers.