PARIS and TARRYTOWN, N.Y., April 5, 2012 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review of the Biologics License Application (BLA) for the investigational agent ZALTRAP® (aflibercept) concentrate for solution for infusion in combination with the irinotecan-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer (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 marketed products. Under Priority Review, the target date for an FDA decision on the ZALTRAP BLA is August 4, 2012. The filing was based on the Phase III VELOUR study in patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen.
"Sanofi and Regeneron are committed to the continued development of ZALTRAP and we are very pleased that the FDA has chosen to grant Priority Review to ZALTRAP in metastatic colorectal cancer," said Debasish Roychowdhury, M.D., Senior Vice President and Head, Sanofi Oncology. "We look forward to working closely with the FDA to potentially bring an important new option to patients with this difficult disease."
Separately, the companies today announced the results from the Phase III VENICE trial evaluating the addition of the investigational agent 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 (OS). 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.About the VELOUR Phase III Study The VELOUR study was a multinational, randomized, double-blind trial comparing ZALTRAP versus placebo in combination with FOLFIRI in the treatment of patients with mCRC after failure of an oxaliplatin-based regimen. The study enrolled 1,226 patients with mCRC. The primary endpoint was an improvement in overall survival. Secondary endpoints included progression-free survival, response to treatment, and safety.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV