Sanofi and Regeneron have announced varied fortunes for their cancer drug Zaltrap, with the drug gaining a quick evaluation in the USA for colorectal cancer, but failing in a late-stage prostate cancer clinical trial.
Sanofi announced today that the US Food and Drug Administration (FDA) has granted priority review of the Biologics License Application for Zaltrap (aflibercept) in combination with the irinotecan-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer (mCRC) formerly treated with an oxaliplatin-containing regimen.
The target date for a decision by the US Food and Drug Administration regulatory agency has been set for August 4th.
Priority review is granted if initial estimates demonstrate that the drug has the potential to provide a treatment where no adequate therapy exists, or where there is a significant improvement in comparison with current marketed products.
The submission was founded on the Phase III VELOUR research study which compared Zaltrap, in combination with the FOLFIRI chemotherapy regimen, and FOLFIRI with a placebo. The clinical trial successfully met its primary endpoint of improving overall survival in the second-line treatment of mCRC.
Late-Stage Trial Failure
However, Sanofi and Regeneron have also reported bad results from the Phase III VENICE trial, 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 clinical research study did not meet the pre-specified criterion of improvement in overall survival.
“Sanofi and Regeneron are committed to the continued development of Zaltrap,” Sanofi oncology head Debasish Roychowdhury announced in a statement.
Outside of oncology, Regeneron and partner Bayer received US approval for Zaltrap for the treatment of patients with wet age-related macular degeneration in November. The drug was approved under the brand name Eylea and is also known as VEGF Trap-Eye.