ImClone Systems Submits Supplemental Biologics License Application for ERBITUX in Treatment of Squamous Cell Carcinoma of the Head and Neck

Strategic Insights -

ImClone Systems Incorporated and Bristol-Myers Squibb announced that ImClone Systems has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration for approval of ERBITUX in the treatment of squamous cell carcinoma of the head and neck. The application seeks marketing approval for the use of ERBITUX in combination with radiation for locally or regionally advanced SCCHN, and as monotherapy in patients with recurrent and/or metastatic SCCHN where prior platinum-based chemotherapy has failed or would not be appropriate. The submission is based on the results of two clinical trials presented at the 2004 Annual Meeting of the American Society of Clinical Oncology, along with other supportive data. The companies also announced that ImClone Systems has requested priority review of the application.

Key Takeaways:

  • ImClone Systems submitted a supplemental Biologics License Application to the FDA for approval of ERBITUX in the treatment of SCCHN.
  • The application seeks marketing approval for the use of ERBITUX in combination with radiation for locally or regionally advanced SCCHN, and as monotherapy in patients with recurrent and/or metastatic SCCHN.
  • The submission is based on the results of two clinical trials: a randomized, international Phase 3 trial and an open-label, multicenter Phase 2 trial.
  • ImClone Systems has requested priority review of the application.
  • ERBITUX binds specifically to epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands.
  • Over-expression of EGFR is detected in many human cancers, including those of the colon and rectum.
  • ImClone Systems is developing targeted biologic treatments for a variety of cancers.
  • Bristol-Myers Squibb is working to discover and develop cancer fighting therapies.

Statistics:

  • 424 patients were enrolled in the randomized, international Phase 3 trial.
  • 103 patients were enrolled in the open-label, multicenter Phase 2 trial.
  • ERBITUX was approved by the FDA on February 12, 2004, for use in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer.
  • ERBITUX was also approved by the FDA for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy.

Sources:

  • Health & Medicine Week editors from staff and other reports
  • NewsRx.com
  • ImClone Systems Incorporated
  • Bristol-Myers Squibb
  • American Society of Clinical Oncology (ASCO)
  • Merck KGaA, Darmstadt, Germany
  • European Medicines Agency (EMEA)
  • Swissmedic