EU CHMP recommends approval of Fotivda (tivozanib) for patients with advanced renal cell carcinoma- EUSA Pharma

EUSA Pharma announced that 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 authorisation 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-na�ve 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, which 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.