FDA will review a drug candidate for kidney cancer from AVEO and Astellas
AVEO Oncology, a Cambridge-based cancer therapeutics company, and its Japanese partner Astellas Pharma Inc. said Wednesday that federal regulators have agreed to review its drug candidate for kidney cancer.
In a press release, the companies said that the Food and Drug Administration has accepted their new drug application for tivozanib, a treatment for patients with advanced renal cell carcinoma, or kidney cancer. To date, tivozanib is an investigational medicine and is not currently approved in any country. If tivozanib gets regulatory approval, AVEO said the proposed brand name for the drug is TIVOPATH.
According to the timelines established by the Prescription Drug User Fee Act, the review of tivozanib’s new drug application is expected to be complete by July 28, AVEO and Astellas said. The FDA’s acceptance of the application triggers a $15 million milestone payment to AVEO under its development and commercialization agreement with Astellas.Chris Reidy can be reached at firstname.lastname@example.org.