Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Sanofi, Regeneron Say FDA Grants Priority Review To Zaltrap In Cancer

RELATED NEWS
Trade SNY now with 

Sanofi (SNY: Quote) and Regeneron Pharmaceuticals, Inc. (REGN) on Thursday said that the Biologics License Application for the investigational agent Zaltrap (aflibercept) concentrate for solution has been granted priority review by the Food and Drug Administration.

Zaltrap is proposed for infusion in combination with the irinotecan-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer, or mCRC, previously treated with an oxaliplatin-containing regimen.

A priority review designation is given to drugs if preliminary estimates indicate that the drug product, if approved, has the potential to provide a treatment where no adequate therapy exists or a significant improvement compared to products already available on the market.

Under priority review, the target date for an FDA decision on the Zaltrap BLA is August 4. The filing was based on the Phase III Velour study in patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen.

Separately, the companies announced the results from the Phase III VENICE trial evaluating the addition of Zaltrap to a regimen of docetaxel and prednisone for the first-line treatment of metastatic androgen-independent prostate cancer. The study did not meet the pre-specified criterion of improvement in overall survival. The safety profile was generally consistent with previous studies of Zaltrap in combination with docetaxel.

The companies are conducting a detailed analysis of the VENICE data, and full results will be presented at an upcoming medical meeting.

Register
To receive FREE breaking news email alerts for Sanofi and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
After moving mostly higher in early trading on Tuesday, stocks have given back ground over the course of the trading session. A negative reaction to news of new European sanctions against Russia contributed to the pullback by the markets. Consumer confidence in the U.S. improved for the third consecutive month in July, according to a report released by the Conference Board on Tuesday, with the consumer confidence index jumping to its highest level in almost seven years. Stocks have moved mostly higher in early trading on Tuesday after ending the previous session roughly flat. The major averages have climbed into positive territory, although there does not seem to be much conviction behind the upward move.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.