logo
Share SHARE
FONT-SIZE Plus   Neg

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

Sanofi (SNY) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
PayPal has agreed to buy Xoom, a digital money transfer provider, for $890 million in cash. Following the announcement, Xoom shares jumped 22 percent in after-hours trade on the Nasdaq. Discount retailer Family Dollar Stores Inc., which is being acquired by rival Dollar Tree Inc., said Wednesday after the markets closed that its third quarter profit fell slightly from last year, due mainly to a higher effective tax rate. The company's quarterly earnings per share, excluding items, also came in below analysts' expectations. Most of the major automakers, except General Motors Co. (GM), Wednesday reported improved sales results for June, as strong sales of trucks and SUVs continued to help offset weak car sales. Nonetheless, GM's June U.S. sales dropped 3 percent to 259,353 units from 267,461 units last year. The drop...
comments powered by Disqus
Follow RTT