Sanofi has reported mixed fortunes for its oncology drug Zaltrap, partnered with Regeneron, with the treatment getting a speedy review in the USA for colorectal cancer but failing in a late-stage prostate cancer trial.
First up, the French drugmaker says the US Food and Drug Administration 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) previously treated with an oxaliplatin-containing regimen. This means that a target date for a decision by the agency has been set for August 4.
The filing was based on the Phase III VELOUR study which compared Zaltrap in combination with the FOLFIRI chemotherapy regimen versus FOLFIRI plus placebo. The trial met its primary endpoint of improving overall survival in the second-line treatment of mCRC.
However the bad news saw Sanofi and Regeneron report headline 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.
Outside of oncology, Regeneron and partner Bayer received US approval for aflibercept 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.