The FDA ( Food and Drug Administration ) has approved Erbitux ( Cetuximab ) for use with chemotherapy to treat patients with metastatic head and neck cancer.
Combined with chemotherapy, Erbitux extended the lives of those receiving the treatment combination compared with those receiving chemotherapy alone.
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 ).

According to the National Cancer Institute, head and neck cancers account for 3% to 5% of all cancers in the United States. These cancers typically develop in the nose, throat or mouth and they are more common in men and in people older than 50.

The safety and effectiveness of Erbitux for this indication is based on the results of a multicenter clinical study conducted outside the United States involving 442 patients with metastatic or recurrent head and neck cancer.
The study used a non-U.S. approved version of Cetuximab, rather than the U.S.-approved formulation.

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 chemotherapy ( Cisplatin or Carboplatin and 5-Fluorouracil ) only.
Patients receiving the Cetuximab with chemotherapy combination lived, on average, 10.1 months compared with 7.4 months for those receiving chemotherapy only.

The most common side effects reported in patients receiving Cetuximab were rash, itching, nail changes, headache, diarrhea, and respiratory, skin, and mouth infections. Erbitux also can cause low serum magnesium, potassium, and calcium.
Erbitux has been associated with serious and potentially life-threatening infusion reactions and heart attack.
Patients taking Erbitux should limit their exposure to the sun.

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.

Source: FDA, 2011

XagenaMedicine2011