FDA APPROVES ERBITUX¨ (Cetuximab) FOR TREATMENT OF
ÐFirst and Only Approved Monoclonal Antibody for
Squamous
Cell Carcinoma of the Head and Neck Ð
New York, NY & Princeton, NJ Ð March 1, 2006 Ð ImClone
Systems Incorporated (NASDAQ: IMCL) and Bristol-Myers Squibb Company (NYSE:BMY)
announced today that the U.S. Food and Drug Administration (FDA) has approved
ERBITUX¨ (Cetuximab), an IgG1 monoclonal antibody, for use in the
treatment of squamous cell carcinoma of the head and neck. Designed to
inhibit the function of the epidermal growth factor receptor (EGFR) Ð a
molecular structure linked to tumor growth Ð ERBITUX is the first and only
monoclonal antibody to be approved for the treatment of head and neck
cancer.
With this approval, ERBITUX is now indicated for use in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and as a single agent in recurrent or metastatic SCCHN where prior platinum-based chemotherapy has failed. These indications are based on a Phase III study Ð one of the largest studies ever conducted in head and neck cancer patients Ðthat demonstrated a survival and loco regional control advantage when ERBITUXwas added to radiation therapy, and a Phase II study, where ERBITUX therapy alone reduced tumor size.
ÒThis is an important milestone as ERBITUX is the first FDA approved therapy for head and neck cancer patients in more than 30 years,Ó said Kie-Kian Ang, M.D.,Ph.D., Professor, Radiation Oncology, Deputy Chair, Radiation Oncology, Deputy Division Head, Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas. ÒFor patients with locally or regionally advanced disease, ERBITUX in combination with radiation therapy has demonstrated a clinically significant improvement in survival and loco regional control.Ó
Ina pivotal, international, randomized Phase III trial of 424 patients with locally or regionally advanced squamous cell carcinoma of the oropharynx, hypopharynx or larynx with no prior therapy, the addition of ERBITUX to radiation (n=211) when compared to radiation alone (n=213) resulted in a 9.5-month improvement in median duration of loco regional control [24.4 months versus 14.9 months, p = 0.005, hazard ratio, 0.68, 95% Confidence Interval (0.52-0.89)]. ERBITUX was dosed weekly, starting one week before radiation and for the duration of radiation therapy. The median number of ERBITUX doses administered in the clinical study was eight (1-11 infusions). Results also showed a 19.7-month improvement in median survival [49.0 months versus 29.3 months, p=0.03, hazard ratio, 0.74, 95%Confidence Interval (0.57-0.97)].
Another principal trial was a single-arm, multi center, Phase II trial studying the effects of ERBITUX as a single-agent treatment. The study analyzed 103patients with recurrent or metastatic SCCHN not suitable for further local therapy and who had failed platinum-based chemotherapy. ERBITUX was administered until disease progression or unacceptable toxicity. The median number of doses was 11 (range 1-45 infusions). Patients demonstrated a clinically meaningful objective response rate of 13 percent (95% Confidence Interval 7%-21%). The median duration of response was 5.8months (range 1.2-5.8 months).
Pretreatment assessment for
evidence of EGFR expression is not required for patients with squamous cell
carcinoma of the head and neck.
ÒThis approval is a significant advancement for ImClone Systems and its partners,Ó said Joseph L. Fischer, Interim Chief Executive Officer, ImClone Systems Incorporated. ÒWe continue to support abroad, evidence-based development plan for ERBITUX with the goal of fully demonstrating the therapyÕs potential in treating human cancers.Ó
ÒERBITUX represents an important new option for potentially thousands of patients fighting head and neck cancer, a serious disease for which there is significant unmet medical need," said Peter R. Dolan, Chief Executive Officer, Bristol-Myers Squibb. "These new indications for ERBITUX are another step forward in our company's commitment to helping patients with cancer, and building on our decades-long legacy of researching, developing and providing innovative anti-cancer therapies to patients around the world."
This is the second indicated tumor type for ERBITUX, previously approved by the FDA for use in combination with irinotecan for patients with EGFR-expressing metastatic colorectal cancer who are refractory to irinotecan therapy and as a single-agent for the treatment of EGFR-expressing metastatic colorectal cancer in patients who are intolerant to irinotecan therapy. The effectiveness of ERBITUX for the treatment of EGFR-expressing metastatic colorectal cancer is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX for the treatment of EGFR-expressing metastatic colorectal cancer.
ERBITUX was granted approval by Swiss Medic in December 2005 for use in combination with radiation in the treatment of patients with previously untreated advanced head and neck cancer. A similar marketing application was recommended for approval by a European Medicines Agency scientific advisory panel.