Eli Lilly and Bristol-Myers Squibb have won expanded approval in the USA for the cancer drug Erbitux.
The US Food and Drug Administration has given the green light to Erbitux (cetuximab) for use with chemotherapy to treat patients with late-stage head and neck cancer. The expanded approval is based on a 442-patient study in people with metastatic or recurrent head and neck cancer who had not received prior chemotherapy, which was carried out some years ago by the European Erbitux partner Merck KGaA.
That data showed that patients receiving Erbitux with chemotherapy combination lived, on average, 10.1 months compared with 7.4 months for those receiving chemotherapy only. Richard Pazdur, director of the Office of Hematology and Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said that “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 multi-treatment approach for patients”.
He added that "given the aggressive nature of head and neck cancers that cannot be treated with surgery and radiation, it is important that patients have as many treatment options available as possible.” Erbitux already is FDA-approved for certain types of colon cancer, and has been approved since 2006 for treatment of non-metastatic head and neck cancer in combination with radiation therapy (first-line) or as a single agent (following standard treatment). It is already available in Europe for the late-stage head and neck cancer indication.