Sanofi and Regeneron Pharmaceuticals Received FDA Priority Review for The BLA of ZALTRAP

Sanofi and Regeneron Pharmaceuticals have received FDA priority review for the biologics license application (BLA) of ZALTRAP (aflibercept) as a treatment for metastatic colorectal cancer (mCRC).

The filing was based on the Phase III VELOUR study in patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen.

The companies have also announced the trial data, which evaluated the addition of ZALTRAP to a regimen of docetaxel and prednisone for the first-line treatment of metastatic androgen-independent prostate cancer.

The study failed to meet the pre-specified criterion of improvement in overall survival (OS).

Sanofi Oncology head senior vice president Debasish Roychowdhury said: "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."