Tuan Ha-Ngoc, CEO, AVEO Oncology
AVEO Oncology (Nasdaq: AVEO) and its Japanese partner Astellas Pharma, have submitted kidney cancer drug candidate tivozanib to the U.S. Food and Drug Administration.
In advance of the submission, Cambridge, Mass.-based AVEO has been beefing up its staff, and in May, inked a deal for a new, larger headquarters.
If approved, it would be the first drug on the market developed by AVEO. The companies are seeking approval for treatment of patients with advanced renal cell carcinoma.
The partners presented positive Phase 3 clinical trial results for tivozanib at the American Society of Clinical Oncologists meeting in June. The study showed that tivozanib was the first product to demonstrate more than one year of progression-free survival for patients who had never taken medication for the disease before. In a head-to-head comparison, AVEO?s drug candidate bested Nexavar, the current standard of care, made by Onyx Pharmaceuticals (Nasdaq: ONXX).
More than 100,000 people die from renal cell carcinoma worldwide each year, the company said.
AVEO is expecting a standard, 10-month review from the FDA.
Source: http://www.masshightech.com/stories/2012/09/24/daily53-AVEO-submits-kidney-cancer-drug-to-FDA.html
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