Sanofi (SNY) and Regeneron Pharmaceuticals Inc. (REGN) announced that the U.S. Food and Drug Administration or FDA approved Zaltrap or ziv-aflibercept Injection for Intravenous Infusion, in combination with 5-fluorouracil, leucovorin, irinotecan or FOLFIRI, for patients with metastatic colorectal cancer or mCRC that is resistant to or has progressed following an oxaliplatin-containing regimen.
The companies said that the Marketing authorization applications for Zaltrap are also under review by the European Medicines Agency (EMA) and other regulatory agencies worldwide.
Sanofi said it plans to make Zaltrap available in the U.S. in the third quarter of 2012. As per the terms of their collaboration agreement, Sanofi and Regeneron share equally the global profits of Zaltrap after Regeneron's obligation to repay its share of development expenses. In the U.S., Zaltrap is a registered trademark of Regeneron Pharmaceuticals, Inc.
Zaltrap is an angiogenesis inhibitor that inhibits the blood supply to tumors. It is intended for patients whose cancer has spread to other parts of the body (metastatic) and whose tumors are resistant to or progressed after an oxaliplatin-containing chemotherapy regimen.
The FDA said that Zaltrap is being approved with a Boxed Warning alerting patients and health care professionals that the drug can cause severe and sometimes fatal bleeding, including gastrointestinal bleeding, and the development of holes in the gastrointestinal tract. Zaltrap can also make it more difficult for wounds to heal.
The most common side effects observed in patients receiving Zaltrap plus FOLFIRI were decreased white blood cell count, diarrhea, mouth ulcers, fatigue, high blood pressure, increased amount of protein in the urine, weight loss, decreased appetite, abdominal pain, and headache.
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