• 6/26/2005
  • New York City, NY
  • press release
  • Genetic Engineering News (www.genengnews.com)

ImClone Systems Incorporated announced today that, following discussions with the FDA, the Company intends to submit a supplemental Biologics License Application (sBLA) to seek approval for use of Erbitux(R) (Cetuximab) in combination with radiation and as a single agent in Squamous Cell Carcinoma of the Head and Neck (SCCHN) in the third quarter of 2005. The following clinical trials would serve as the basis of the sBLA, together with other supportive data:

1. a randomized, international phase III trial (IMCL-9815), conducted by ImClone Systems and Merck KGaA, presented at the 2004 American Society of Clinical Oncology (ASCO) annual meeting examining the impact of combining Erbitux with radiation on locoregional control and overall survival in 424 patients with locally advanced SCCHN.

and

2. a multicenter phase II trial (EMR-016) conducted by Merck KGaA presented at the 2004 ASCO annual meeting evaluating the response rate of Erbitux as a single agent in 103 patients with advanced recurrent and/or metastatic SCCHN not suitable for further local therapy and who have failed platinum-based chemotherapy.

About Head and Neck Cancer

According to the American Cancer Society, approximately 40,000 Americans will be diagnosed with oral, head and neck cancer this year, including cancers of the tongue, mouth, pharynx, and larynx. More than 11,000 will die from the disease in 2005.

About Erbitux (Cetuximab)

On February 12, 2004, the FDA approved Erbitux for use in the United States in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy. The effectiveness of Erbitux is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Erbitux.