FDA approves Sanofi colon cancer drug, Zaltrap

Hannah Blake

pharmaphorum

The US Food and Drug Administration (FDA) has announced it has approved colon cancer drug, Zaltrap, for use in combination with a folinic acid, fluorouracil and iriontecan (FOLFIRI) chemotherapy regimen.

Zaltrap (aflibercept) is an angiogenesis inhibitor that inhabits the blood supply to tumours. It is intended for adult patients whose cancer has spread to other parts of the body and whose tumours are resistant to or progressed after an oxaliplatin-containing chemotherapy regimen.

In a large clinical trial, those patients who took Zaltrap in combination with FOLFIRI, lived an average of 13.5 months, compared with 12 months for those receiving only FOLFIRI. Also, patients receiving Zaltrap went an average 6.9 months before their symptoms got worse, compared with patients on chemotherapy alone, who went 4.7 months.

“This approval demonstrates the benefits of adding a biological agent, Zaltrap, to a commonly used chemotherapy drug regimen, FOLFIRI. An improvement in median survival time was noted with the addition of Zaltrap to FOLFIRI, accompanied by an improvement in response rate and a delay in tumour progression and growth.”

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

In the United States, colorectal cancer is the fourth most commonly diagnosed cancer and in 2012, an estimated 143,460 Americans will be diagnosed, according to the National Institutes for Health.

Zaltrap, developed by Sanofi and Regeneron Pharmaceuticals, will compete with Roche Holding AG’s Avastin (bevacizumab) and Bristol-Myers Squibb Co's Erbitux (cetuximab).