lundi 6 août 2012

FDA approves Zaltrap for metastatic colorectal cancer

            The U.S. Food and Drug Administration recently approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer.

            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.

            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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