Bristol-Myers announces availability of ERBITUX for metastatic colorectal cancer treatment

Bristol-Myers Squibb Canada is pleased to announce that the Ontario government has made ERBITUX(TM) (cetuximab) available to patients suffering from metastatic colorectal cancer. This decision makes Ontario the second province, after British Columbia, to introduce funding for this important treatment option and represents encouraging news for those patients who rely on provincial drug coverage and stopped responding to standard treatments for metastatic colon cancer.

The addition of ERBITUX to the list of publicly reimbursed anticancer medications in Ontario is testament to the high level of evidence to support its safety and clinical effectiveness.

"There is strong clinical data to support the use of cetuximab in patients with advanced colorectal cancer. Having access to this important option will make an appreciable difference," explained Dr. Derek Jonker, oncologist at the Ottawa Cancer Centre. "Access to the latest proven advancements allows us to make treatment choices that ensure the best possible patient care to our patients."

The randomized multi-centre Phase II trial known as the "BOND" study provided the clinical evidence supporting the use of ERBITUX in combination with irinotecan or with chemotherapy. In this study, the combination therapy demonstrated a significant response rate of 22.9%, a time to progression of 4.1 months, and resulted in 55.5% of patients to either get a response or stabilize their disease. Also of note, the significantly higher response rate (25.8%) and longer time to progression with irinotecan-refractory tumors suggests that cetuximab + irinotecan may circumvent irinotecan resistance. Finally, a median survival of 8.6 months was reported for the intent-to-treat population although the study was not designed to demonstrate a survival advantage.

This year in Canada, an estimated 22,000 people will be diagnosed with colorectal cancer, the second leading cause of cancer deaths in the country. Nearly one quarter of these patients have metastatic disease, or cancer that has spread to other organs, at the time of diagnosis.

"The decision regarding ERBITUX is without doubt, very positive news for patients with advanced colorectal cancer. Equal access to a range of proven treatment options is imperative in this field," said Colleen Savage, president of the Cancer Advocacy Coalition of Canada. "We hope that all provinces will follow the example of British Columbia and Ontario to improve the standard of colorectal cancer treatment across Canada."

British Columbia and Ontario cancer patients with wild-type KRAS after failure of oxaliplatin, and irinotecan-containing chemotherapy regimens will be eligible for treatment with ERBITUX in combination with irinotecan, for the treatment of EGFR-expressing metastatic colorectal cancer as third-line therapy in patients. ERBITUX will be paid for under the Ministry's New Drug Funding Program. In British Columbia, the BC Cancer Agency has listed ERBITUX as a treatment to patients previously treated with fluorouracil, irinotecan and oxaliplatin whose metastatic colorectal cancer is no longer responding.

Bristol-Myers Squibb Canada continues to collaborate with officials in each province as they evaluate the ERBITUX file.