FDA gives new approval to Bristol-Myers Squibb's, Lilly's Erbitux

Drug approved for late-stage head and neck cancers

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb and Eli Lilly & Co. for treating head and neck cancer, the agency said Monday.

The FDA announced the approval of Erbitux (cetuximab) for use with chemotherapy in treating head and neck cancer that had spread to other parts of the body. The drug originally was approved in 2004 for treating certain cases of late-stage colon cancer in patients who had stopped responding to chemotherapy.

"Erbitux's ability to extend the lives of patients with head and neck cancers is an important tool for oncologists who often rely on a multitreatment approach for patients," FDA Office of Hematology and Oncology Drug Products director Richard Pazdur said. "Given the aggressive nature of head and neck cancers that cannot be treated with surgery and radiation, it is important for patients to have as many treatment options available as possible."


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