Zaltrap gains US approval for metastatic colorectal cancer

The US Food and Drug Administration on Friday approved French drug major Sanofi (Euronext: SAN) and US partner Regeneron Pharmaceuticals’ (Nasdaq: REGN) Zaltrap (ziv-aflibercept) injection for intravenous infusion, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.

Shares of Sanofi rose 3.7% to $41.49 in afternoon trading in the USA, while Regeneron stock edged up around 1% to $137.33 on the news.

Zaltrap was approved following a Priority Review by the FDA, a designation given to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. Marketing authorization applications for Zaltrap are also under review by the European Medicines Agency, which is expected to give its decision in the fourth quarter, and other regulatory agencies worldwide. Sanofi said it expects to make the drug available in the USA during the third quarter of this year.