AVEO Pharma agrees submission terms with CHMP for tivozanib as a treatment for renal cell carcinoma

AVEO Oncology announced that, following pre-submission advisory meetings to discuss the potential submission of a Marketing Authorization Application (MAA) for tivozanib in Europe for the treatment of renal cell carcinoma (RCC), it has received written confirmation of support from the Rapporteur and co-Rapporteur for the filing of such an application. The Rapporteur (from Portugal) and Co-Rapporteur (from the United Kingdom) are the two appointed members of the Committee for Medicinal Products for Human Use (CHMP) who would lead the evaluation of the MAA, if submitted. The application would be based on the Company's existing dataset, which includes results from the Phase III TIVO-1 study of tivozanib in the first-line treatment of RCC in which tivozanib demonstrated a significant improvement over sorafenib in the study's primary endpoint of progression free survival. At the advisory meetings, AVEO provided data demonstrating that the discordance in overall survival (OS), the secondary endpoint of the study, was very likely attributable to the crossover design of the study.

Comment: The FDA Advisory Committee in May 2013 voted that tivozanib did not demonstrate a favourable benefit to risk evaluation against Nexavar (sorafenib) and required a new Phase III trial for the application to proceed. Astellas withdrew from the collaboration in May 2013.