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

Quick Facts

Editors Pick
H&R Block reported a smaller loss for the first quarter, driven by a four percent increase in revenues, partly offset by foreign currency fluctuations. The company announced a $3.5 billion stock buyback, and its shares gained 7% in after-hours trade... About nine-tenths of the world's sea birds are likely to have consumed pieces of plastic which continue to remain in their guts, a study shows. Automakers reported some mixed U.S. sales for August, marked by fewer working days and a delayed Labor Day, even as the month was largely bullish, spurred by lower interest rates, cheaper gas, and some strong employment data that buoyed consumer confidence.
comments powered by Disqus
Follow RTT