FDA accepts B-MS/ImClone's Erbitux sBLA

US biotechnology firm ImClone Systems and drug major and Bristol-Myers Squibb say that the Food and Drug Administration has accepted for filing and review the companies' supplemental Biologics License Application to broaden the indication for Erbitux (cetuximab) to include use in combination with platinum-based chemotherapy for the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The companies also announced that, as requested, the application has been granted a priority review designation by the FDA.

The sBLA submission is based on data from the randomized Phase III EXTREME study1 investigating the efficacy of the drug in combination with platinum-based chemotherapy in the first-line treatment of patients with recurrent or metastatic SCCHN. The study was conducted by Merck KGaA of Germany, the partner of ImClone for Erbitux outside North America, and showed that the drug, in combination with platinum-based chemotherapy, resulted in a statistically-significant improvement in median overall survival time compared with chemotherapy alone.

If approved, this will be the third US indication in head and neck cancer. Erbitux was initially approved to treat locally- or regionally-advanced SCCHN in combination with radiation therapy, and as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed, in March 2006.