EUSA Pharma, AVEO Announce Submission of Marketing Authorization Application to EMA for Tivozanib in Advanced Renal Cell Carcinoma

EUSA Pharma, a newly-established specialty pharmaceutical business, and AVEO Oncology AVEO today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for tivozanib for the first-line treatment of advanced renal cell carcinoma (RCC). The filing is based on tivozanib's existing dataset and follows positive interactions with the Rapporteur and Co-Rapporteur during 2015 which indicated support for a filing using the phase III TIVO-1 trial as the pivotal study. EUSA Pharma submitted the application under the European Union's centralized procedure, which permits the agency to issue a single marketing authorization that is valid across all EU countries. Under the companies' license agreement announced in December 2015, EUSA holds exclusive commercialization rights to tivozanib in RCC in Europe and in a number of other territories outside North America, including South America and South Africa, in addition to a range of further indications. Under the terms of the agreement, EUSA Pharma will undertake and fund the commercialization of the product in its territories, assuming approval.