EU approves Erbitux for SCCHN

German drugmaker Merck KGaA says that the European Commission has granted a marketing authorization extension to its cancer drug Erbitux (cetuximab), allowing its use in combination with radiotherapy for the treatment of patients with locally-advanced squamous carcinoma of the head and neck. The approval covers all 25 member states of the European Union, in addition to Iceland and Norway. The drug is already available as a treatment for metastatic colorectal cancer in patients who have experienced failed prior irinotecan-based chemotherapy.

Marketing authorization is based on data from an international Phase III study of the product in 424 patients. The work demonstrated that, for subjects treated with the agent in combination with radiotherapy, median survival duration improved to 49.0 months, an increase on the 29.3 month survival time achieved by radiotherapy alone. The duration of locoregional control also improved, reaching 24.4 months, compared with the 14.9 month period produced by the radiotherapy regimen. Commonly reported side effects of the drug included an acne-like skin rash.

The firm says that its product, which is the first targeted therapy to be approved for SCCHN, meets the need for an effective treatment option for this complicated disease.