US drugmaker Bristol-Myers Squibb and Montreal, Canada-based Imclone System’s cancer drug Erbitux (cetuximab) has been approved by Health Canada for the treatment of colorectal cancer.

Erbitux has been cleared for use in combination with Aventis’ Campto (irinotecan) for the treatment of patients with epidermal growth factor receptor-expressing, metastatic colorectal cancer who are refractory to other irinotecan-based chemotherapy, and as single agent therapy for patients who are intolerant to such chemotherapy.

“Erbitux is a promising a new option for patients in whom irinotecan-based chemotherapy is no longer effective or tolerated,” commented Dr Derek Jonker of the Regional Cancer Centre in Ottawa, Canada. “Clinical studies indicate that non-chemotherapeutic molecular drugs are effective in treating metastatic colorectal cancer,” he added.

However, the news was slightly marred by an earlier report that the US Food and Drug Administration has issued a new warning to doctors requesting that patients using Erbitux for the treatment of colorectal cancer should be monitored for an hour after they receive each injection, due to potential reactions that include trouble with breathing, hives or dangerously low blood pressure. According to the FDA, around 3% of patients receiving Erbitux have suffered a severe reaction, but fatalities seem to be rare, at fewer than one-tenth of 1%.

Furthermore, the drug’s label now calls for patient monitoring at regular intervals for several weeks after injection due to electrolyte depletion.

Erbitux has certainly had a chequered history. The agent was first cleared for use by the US Food and Drug Administration in February last year [[13/02/04b]], finally overcoming substantial hurdles such as the FDA’s refusal to file a letter on clinical trial protocol violations, and company executives’ involvement in a much-publicised insider trading scandal.