Sanofi's Zaltrap gets EU approval for metastatic colorectal cancer

In a second European approval within a matter of days, French drug major Sanofi (Euronext: SAN) said yesterday that the EuropeanCommission has  granted marketing authorization for Zaltrap (aflibercept) – partnered with the USA’s Regeneron (Nasdaq: REGN) - in combination with FOLFIRI chemotherapy in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen. This decision was based on the efficacy and safety results of the VELOUR Phase III trial.

Zaltrap’s approval comes a day after the European Commission gave the green light to Sanofi's diabetes drug Lyxumia (lixisenatide; The Pharma Letter February 4).

“ZALTRAP is an important addition to the metastatic colorectal cancer treatment landscape and helps to fill a critical treatment gap,” said Eric Van Cutsem, of the University Hospitals Leuven, Belgium and lead investigator of the VELOUR study, adding: “ZALTRAP is the first and only agent to demonstrate a statistical survival improvement in a Phase III trial in patients previously treated with an oxaliplatin-based regimen who are being treated with FOLFIRI for their metastatic disease.”