The FDA approved Erbitux (cetuximab) for use with chemotherapy to treat patients with late-stage (metastatic) head and neck cancer. Combined with chemotherapy, Erbitux extended the livers of those receiving the treatment combination compared to those receiving chemotherapy alone.
Erbitux was already approved by the FDA for use in 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). Head and neck cancers typically develop in the nose, throat or mouth and they are more common in men and in people over 50 years of age.
The safety and efficacy of Erbitux for this indication is based on results of a multi-center clinical study involving 442 patients with metastatic or recurrent head and neck cancer. All participants had inoperable or widespread disease and had not received prior chemotherapy. Half were selected to receive either the combination of cetuximab with chemotherapy (cisplatin or carboplatin and 5-fluorouracil) or only chemotherapy (cisplatin or carboplatin and 5-fluorouracil). Patients receiving the cetuximab with chemotherapy combination lived, on average, 10.1 months compared with 7.4 months for those receiving only chemotherapy.
The most common side effects reported in patients receiving cetuximab were rash, itching (pruritus), nail changes, headache, diarrhea, photosensitivity, and respiratory, skin, and mouth infections. Erbitux can also cause low serum magnesium, potassium, and calcium. It has been associated with serious and potentially life-threatening infusion reactions and heart attack.
Erbitux was first approved by the FDA in 2004 to treat Epidermal Growth Factor Receptor (EGFR)-positive late-stage colon cancer after patients stopped responding to chemotherapy. The treatment can be used alone or in combination with chemotherapy.
Erbitux is co-marketed by New York City-based Bristol-Myers Squibb and Eli Lilly and Company based in Indianapolis, Ind.