New US indication for Erbitux

The FDA has again extended the indication for Erbitux (cetuximab) and approved the treatment for patients with advanced head and neck cancers in combination with chemotherapy.

The extension is based on the EXTREME study of 442 patients previously untreated with chemotherapy that demonstrated those treated with Erbitux lived 10.1 months on average, compared with 7.4 months on those treated with chemotherapy alone.

Richard Pazdur, Head of Oncology, FDA, says the medication is an “important tool” for doctors and patients.

Erbitux is now approved for five separate indications across two tumour types and becomes the first regimen in 30 years with extended overall survival in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck to be approved.