Imclone Systems Incorporated and Bristol-Myers Squibb Company announced that Imclone Systems has filed a New Drug Submission (NDS) for the use of Erbitux (cetuximab) in combination with irinotecan for the treatment of patients with Epidermal Growth Factor Receptor (EGFR)-expressing, irinotecan-refractory metastatic colorectal cancer with the Biologics and Genetic Therapies Directorate (BGTD) of Health Canada. The companies also announced that the NDS is being reviewed under Priority Review.
"This filing represents a significant step forward in our global regulatory strategy, including our goal of reaching the greatest number of patients with colorectal cancer that may benefit from the use of Erbitux," stated Daniel S. Lynch, acting chief executive officer of Imclone Systems. "We are pleased to be able to file the NDS under Priority Review with Health Canada following similar Erbitux submissions in the US, Europe and Australia."
"Advanced colorectal cancer strikes people around the world, and there is tremendous unmet medical need in treating it," said Peter R Dolan, chairman and chief executive officer, Bristol-Myers Squibb. "Working with our partners at Imclone Systems, the submission of Erbitux to Health Canada represents a further important step for Bristol-Myers Squibb in reaching out to people with cancer with innovative oncology therapies."
Health Canada's Priority Review is a status granted to eligible New Drug Submissions. Submissions granted Priority Review status will be subject to the following reduced target timeframes: 25 calendar days for submission screening and 180 calendar days for submission review. Priority Review is granted to drug submissions intended for the treatment, prevention or diagnosis of serious, life-threatening illnesses where there is either no existing drug on the Canadian market or where the new product represents a significant improvement over existing products.