AVEO receives European regulatory guidance regarding potential marketing authorisation application for tivozanib

AVEO has received written confirmation of support from two members of the Committee for Medicinal Products for Human Use (CHMP) following pre-submission advisory meetings to discuss the potential submission of a Marketing Authorisation Application (MAA) for tivozanib in Europe for the treatment of renal cell carcinoma (RCC).

The written confirmation of support came from the Rapporteur (from Portugal) and Co-Rapporteur (from the United Kingdom) – the two appointed members of the CHMP who would lead the evaluation of the MAA if submitted.

Tivozanib demonstrated significant improvement over sorafenib in progression free survival

The application would be based on the Company’s existing dataset which includes results from the Phase 3 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. The final meeting minutes reflect that the Rapporteurs “did not see a ‘blocking issue’ with the OS trend” and that AVEO “clearly presented a credible story for the Rapporteurs to assess but one which would need to be supported with very careful reasoning.” AVEO was also reminded that the Rapporteurs “cannot advise on [the] final outcome of the review.”

“We are pleased that both the Rapporteur and Co-Rapporteur were supportive of an MAA filing for tivozanib in RCC using TIVO-1 as the pivotal study” said Michael Bailey president and chief executive officer of AVEO. “We believe tivozanib may provide an important addition to the clinical armamentarium in the treatment of this disease. Based on our assessment of the economic and infrastructure requirements associated with filing an MAA and subsequently launching tivozanib in Europe we are evaluating partnership opportunities to take tivozanib forward in this important market as we continue to prepare for a filing.”