Health Canada approves Velcade for second-line use

VELCADE* (bortezomib) for Injection has received Health Canada approval under a Notice of Compliance with Conditions for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy.

The second-line approval for VELCADE is based on the results of the APEX (Assessment of Proteasome Inhibition on EXtending Remission Results) study comparing the medication to high-dose dexamethasone, a commonly used chemotherapy, in patients with relapsed multiple myeloma. The study demonstrated a significant survival advantage with VELCADE in patients who had received one to three prior therapies. At one-year of follow-up, VELCADE patients had a significantly higher rate of overall survival (80 per cent) versus patients who received dexamethasone (66 per cent). Overall survival was significantly longer among patients who received VELCADE, both for those who had received one previous treatment and for those who had received more than one previous treatment.

“This approval allows patients to use VELCADE at an earlier stage, providing them with a chance at living longer,” comments Dr. Donna Reece, Associate Professor, Department of Medicine at University of Toronto and APEX trial investigator. “I am very pleased about this approval. As a physician, I am always looking for better ways to care for my patients and provide them with additional treatment options. Being able to use VELCADE second-line will have a greater impact on my patients earlier in the treatment process.”

An estimated 6,200 Canadians have multiple myeloma. In 2005, new cases of multiple myeloma were estimated to reach 1,850 and the number of deaths from this disease was estimated at 1,250. Without VELCADE treatment, survival for relapsed, refractory (unresponsive) multiple myeloma patients ranges from six to nine months (the median survival being eight months).

“Multiple myeloma is a difficult cancer to treat, especially when patients fail at least two lines of therapy,” says Dr. Bernard Lemieux, hematologist-oncologist at NotreDame Hospital (CHUM) in Montreal. “Being able to treat patients with VELCADE second-line is significant because it means patients may see a greater benefit earlier in the course of their disease.”

About VELCADE (bortezomib) for Injection

VELCADE offers a completely novel approach to treating multiple myeloma by acting on a unique target in cells called the proteasome. The proteasome is a structure that exists in all cells and plays an important role in breaking down proteins that control how the cell lives and grows.

VELCADE was first approved in Canada under a Notice of Compliance with Conditions in January 2005 for the treatment of patients with multiple myeloma who have relapsed following front-line therapy and are refractory to their most recent therapy. It remains the only treatment in more than a decade to be approved for this group of patients.

VELCADE is reimbursed on a case-by-case basis in British Columbia, Alberta, Saskatchewan, Manitoba, Quebec and the Atlantic provinces. Newfoundland is the most recent province to approve funding for VELCADE. Ortho Biotech continues to pursue coverage for VELCADE in Ontario.

VELCADE has a generally predictable safety profile. In most cases side effects are manageable with appropriate monitoring and if necessary, dose modification. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. In clinical trials, the most commonly reported adverse events include asthenic conditions (including fatigue, malaise and weakness), diarrhea, nausea, constipation, peripheral neuropathy (numbness of the hands, arms, feet or legs), vomiting, fever and thrombocytopenia (decrease in blood clotting cells).

In Canada, VELCADE is marketed by Ortho Biotech, a division of Janssen-Ortho Inc.

* Trademark of Millennium Pharmaceuticals, Inc., all trademark rights used under license.

http://www.orthobiotech.ca