BRISTOL-MYERS SQUIBB CANADA COMMERCIALIZES ERBITUX™ FOR ADVANCED COLORECTAL CANCER
ERBITUX offers patients a new option for treating the disease and receives approval from Health Canada for the treatment of head and neck cancer
product-approval , Head & Neck , Oncology
MONTREAL, CANADA – (October 29, 2008) – In keeping with its commitment to extend and enhance the lives of Canadians through ongoing innovation, Bristol-Myers Squibb Canada (BMS) announced today the commercialization of its innovative cancer medication ERBITUX™ (cetuximab). This news is extremely important to Canadian physicians and their patients suffering from colorectal cancer who have exhausted other available treatments because it will give them a new option to fight this deadly disease.
“Cetuximab will give us another chance to extend and improve the lives of patients with advanced colorectal cancer for whom irinotecan-based chemotherapy is no longer effective or tolerated,” said Dr. Derek Jonker, oncologist at the Ottawa Cancer Centre. “The availability of another treatment option can have a significant impact on these people's lives and their families.”
ERBITUX has been available to patients through Health Canada's Special Access Program (SAP) and the decision by Bristol-Myers Squibb Canada to commercialize ERBITUX will help expand access and improve the lives of more patients who can benefit from it. Strong clinical data to support the use of ERBITUX in patients with advanced colorectal cancer and the recent Health Canada approval of ERBITUX in combination with radiotherapy for the initial treatment of patients with head and neck cancer were key factors in the decision. Bristol-Myers Squibb co-develops and co-commercializes ERBITUX in North America through an agreement with ImClone Systems Incorporated.
“BMS is committed to working with health authorities in all provinces to ensure that cancer patients have ready access to this innovative medication as soon as possible,” said Wayne Quigley, BMS Canada President and General Manager.
New treatment for head and neck cancer
ERBITUX represents a new generation of treatment for head and neck cancer and the first new agent approved for this disease in 45 years. In a phase III clinical trial comparing ERBITUX and radiation therapy to radiation alone, patients who received ERBITUX had significantly improved survival (median survival increased from 29 months to 49 months).
“Cetuximab is an important advance in the treatment of head and neck cancer,” said Dr. Sébastien Hotte, oncologist at the Juravinski Cancer Centre in Hamilton. “The proven clinical benefits achieved with cetuximab in clinical trials represent an exciting new therapeutic option in patients with head and neck cancer at high risk of recurrence with radiation alone.”
ERBITUX is an option for colorectal cancer patients who have not responded adequately to irinotecan-based chemotherapy regimens. It is approved for use in combination with irinotecan for patients with epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer who are refractory to other irinotecan-based chemotherapy regimens. It can also be used as single agent therapy for patients who are intolerant to irinotecan-based chemotherapy.
ERBITUX is a new treatment for head and neck cancer, approved for use in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck.
Colorectal Cancer in Canada
Every year in Canada, an estimated 20,800 people are diagnosed with colorectal cancer, the second leading cause of cancer deaths in the country. Half of these patients have metastatic disease, or cancer that has spread to other organs, at the time of diagnosis.
About Head & Neck Cancer
Head and neck cancer (HNC) is a generic term used when referring to a heterogeneous group of neoplastic tumors, based on an anatomical region including the upper oral cavity, pharynx, and larynx. The majority (90%) of these malignancies are squamous cell carcinomas of the head and neck (SCCHN). SCCHN affoects body sites critical to the vital functions of speech and swallowing leading to devastating effects on quality of life. Locally and regionally advanced SCCHN patients are those who are either diagnosed with or progress to stage III, IVA or IVB cancer.
Head & Neck Cancer in Canada
It is estimated that in Canada in 2008, there will be over 4,600 new cases of head and neck cancer (HNC) diagnosed and nearly 1,700 HNC-related deaths. The five-year survival rate for squamous cell carcinomas of the head and neck (SCCHN) ranges from 27-56%. Locally and regionally advanced SCCHN account for more than half of the total cases of HNC. Most HNC cases occur in men over 50 years of age. Canadian men are 2.5 times more likely than women to be diagnosed with HNC.
About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Bristol-Myers Squibb Canada is a leading provider of medicines to fight cancer, cardiovascular and metabolic disorders, infectious diseases (including HIV/AIDS), nervous system diseases and serious mental illness. Bristol-Myers Squibb Company is listed on the New York Stock Exchange under the BMY symbol (NYSE:BMY). Bristol-Myers Squibb Canada's operations are headquartered in Montréal, Québec.