FDA's Oncologic Drugs Advisory Committee to review NDA for tivozanib

Published on February 27, 2013 at 7:57 AM · No Comments

AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Global Development, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the company's New Drug Application (NDA) for tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC) during the morning session of its meeting on May 2, 2013. ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer, and makes recommendations to the Commissioner of Food and Drugs. According to the timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the NDA is expected to be complete by July 28, 2013.

In November 2012, AVEO and Astellas announced that the FDA accepted for filing the NDA for tivozanib with the proposed indication for the treatment of patients with advanced RCC. The NDA includes results of the global Phase 3 TIVO-1 (TIvozanib Versus sOrafenib in 1st line advanced RCC) trial, a randomized superiority-designed pivotal trial evaluating the efficacy and safety of tivozanib compared to sorafenib, an approved targeted agent, in 517 patients with advanced RCC, as well as data from 16 additional AVEO-sponsored studies involving over 1,000 subjects who received tivozanib. Tivozanib is an investigational medicine and is not currently approved in any country.

Source:

AVEO Oncology

Read in | English | Español | Français | Deutsch | Português | Italiano | 日本語 | 한국어 | 简体中文 | 繁體中文 | Nederlands | Русский | Svenska | Polski
Comments
The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
Post a new comment
Post
You might also like... ×
Alcoholic liver disease: an interview with Dr Vinood Patel, University of Westminster