The US Food and Drug Administration (FDA) has granted Priority Review status to Sanofi and Regeneron Pharmaceuticals, Inc. for their 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 announced the headline 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.

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.

The main objective of the multinational VENICE study (VEGF Trap Administered with Docetaxel in metastatic androgen-independent prostate cancer) was to evaluate the efficacy and safety of the investigational agent Zaltrap (aflibercept) concentrate for intravenous infusion as a first-line treatment in combination with docetaxel and prednisone.  The trial randomized 1,224 patients with metastatic androgen-independent prostate cancer to receive either docetaxel, prednisone and Zaltrap or docetaxel, prednisone and placebo.  The primary endpoint was improvement in overall survival.  Secondary endpoints included Prostate Specific Antigen (PSA) measurement, pain measurement, progression-free survival, and safety.

Zaltrap, also known in the scientific literature as VEGF Trap, is an investigational angiogenesis inhibitor with a unique mechanism of action.  This fusion protein binds multiple forms of Vascular Endothelial Growth Factor-A (VEGF-A), as well as VEGF-B and placental growth factor (PIGF), additional angiogenic growth factors that appear to play a role in tumor angiogenesis and inflammation.  Zaltrap (aflibercept) has been shown to bind VEGF-A, VEGF-B, and PlGF with higher affinity than their native receptors.

Sanofi submitted a regulatory application for marketing approval of Zaltrap for the treatment of previously-treated patients with metastatic colorectal cancer to the European Medicines Agency (EMA) in the fourth quarter of 2011.

Based in Cambridge, Massachusetts, USA and Vitry, France, Sanofi Oncology is dedicated to translating science into effective therapeutics that address unmet medical needs for cancer and organ transplant patients.  

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs.  

Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.