Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

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

Quick Facts

Editors Pick
This apparel maker has doubled its earnings per share in just two years and increased its annual earnings forecast from time to time, despite a challenging consumer spending environment. Contributions from acquisitions, efficiency gains from self-owned global supply chain and benefits from 'Innovate-to-Elevate' strategy continue to boost the company's results. Here is a quick summary of the earnings reported after the bell on Nov 20. We have 20+ stocks listed here. The good news is you can skip this step. There is a next move that can make your life a lot easier. Our research team has already done the groundwork for you. All these stocks listed... Design software maker Autodesk, Inc. said Thursday after the markets closed that its third quarter profit fell 81% from last year, as higher costs and expenses more than offset an 11% increase in revenue. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue.
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.