Posted by Michael Wonder on 01 Feb 2019
AVEO Oncology announces NDA timing update
31 January 2019 - AVEO Oncology today announced that it has accepted the recommendation of the U.S. FDA not to submit a new drug application for tivozanib (Fotivda) with the preliminary overall survival results from the Phase 3 TIVO-3 trial.
The FDA indicated that these preliminary overall survival results do not allay their concerns about the potential detriment in OS outlined in the complete response letter dated 6 June 2013.
The Company now plans to make a filing decision following the availability of more mature overall survival results.
