Velcade approved for use in Canada

Health Canada has approved VELCADE (bortezomib) for Injection for the treatment of patients with multiple myeloma who have relapsed following front-line therapy and are refractory (unresponsive) to their most recent therapy. In a preliminary uncontrolled (Phase II) clinical trial in patients with multiple myeloma, VELCADE demonstrated a median survival of 16 months.

VELCADE was approved under Health Canada’s Notice of Compliance with Conditions Policy that enables physicians and their patients to gain early access to promising new therapies demonstrating clinical effectiveness. VELCADE is the only approved treatment for patients with multiple myeloma who have failed front-line therapy and are unresponsive to their most recent therapy.

VELCADE is a new kind of medication that has been specifically developed to fight cancer by blocking the proteasome, a structure that exists in all cells and plays an important role in breaking down proteins that control how the cell lives and grows. By blocking the proteasome, VELCADE disrupts processes related to the growth and survival of cancer cells. The scientists who conducted the research leading to the development of VELCADE received a Nobel Prize in chemistry in October 2004.

“When multiple myeloma patients fail two previous lines of therapy their cancer is one of the most difficult to treat,” says Dr. Keith Stewart, medical oncologist in Toronto and associate professor, department of medical oncology at the University of Toronto. “But with VELCADE, for the first time, we’re able to give these patients another option which in some cases can extend their lives.”

Research suggests that VELCADE may slow or halt progression of the disease in some patients. In a phase II study of 202 patients, 28 per cent responded to VELCADE.

“This is very encouraging data,” says Dr. Pierre Laneuville, McGill University Health Center Director of Hematology. “It suggests that VELCADE has shown effectiveness in almost three out of 10 multiple myeloma patients who have failed two previous lines of therapy. This should bring renewed hope to multiple myeloma patients and their families.”