The United States Food and Drug Administration (FDA) has accepted ImClone Systems Incorporated and Bristol-Myers Squibb Company's SBLA submission for filing that includes the broadening of the indication of Erbitux® (cetuximab) to include its 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 (SCCHN). As well, the FDA has announced that, as requested, it has granted priority review status for the application. Erbitux is an IgG1 monoclonal antibody, an epidermal growth factor receptor (EGFR) inhibitor.
The new SBLA submission is based on results from the EXTREME (Erbitux in First-Line Treatment of Recurrent or Metastatic head and neck cancer) study, a Phase III trial comparing Erbitux in combination with platinum-based chemotherapy with chemotherapy only in this group of patients. Patients in the Erbitux arm achieved a significant improvement in overall survival compared with those on the chemotherapy-only arm.
Erbitux is already approved for two indications for the treatment of SCCHN; as a single agent among patients who have progressed despite prior platinum-based therapy and in combination with radiation therapy for locally or regionally advanced SCCHN.
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