Erbitux approved by FDA in SCCHN

US firms ImClone Systems and Bristol-Myers Squibb say that the Food and Drug Administration has approved the drug Erbitux (cetuximab) for use in the treatment of squamous cell carcinoma of the head and neck. The drug was initially approved as a treatment for colorectal cancer and, according to the agency, is the first anticancer compound approved for SCCHN since methotrexate became available during the 1950s.

Erbitux is an IgG1 monoclonal antibody designed to inhibit the function of epidermal growth factor receptor expressed on the surface of tumors. Clinical assessment and animal studies have shown that binding of the drug to these receptors prevents the activation of associated receptor kinases which inhibits cell growth, eventually leading to apoptosis.

The FDA's decision is based on data from a pivotal, international, randomized Phase III trial of Erbitux in 424 patients with locally or regionally advanced squamous cell carcinoma of the oropharynx, hypopharynx or larynx. During the assessment, subjects received either Erbitux and radiotherpy (n=211) or radiotherapy alone (n=213). When analyzed, the results showed that the addition of the product conferred a 9.5 month improvement in the median duration of locoregional control (24.4 months versus 14.9 months). The drug also produced a 19.7 month improvement in median survival time compared with radiotherapy alone (49.0 months vs 29.3 months).