May 10, 2006

Velcade (bortezomib) for Injection has received Health Canada approval for the treatment of progressive multiple myeloma (a type of bone marrow cancer) in patients who have received at least one prior therapy and who have already undergone 2.

The approval 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 percent) versus patients who received dexamethasone (66 percent). Overall survival was significantly longer among patients who received the medication.

"This approval allows patients to use Velcade at an earlier stage, providing them with a chance at living longer," said Donna Reece, associate professor in the Department of Medicine at University of Toronto and an APEX trial investigator. "Being able to use Velcade second-line will have a greater impact on patients earlier in the treatment process."