StemCell Therapy

New route of administration provides greater convenience and choice for physicians and patients

TORONTO, March 15, 2012 /CNW/ - Janssen Inc. announced today that Health Canada has approved an expanded indication for VELCADE (bortezomib) to include subcutaneous administration in the treatment of multiple myeloma, a form of blood cancer.1,2 This route of administration was studied in patients with relapsed multiple myeloma. With this approval, Canadians living with multiple myeloma can now receive a convenient, subcutaneous (under the skin) injection that allows for greater physician and patient treatment choice.3 VELCADE was first approved in Canada under a Notice of Compliance with Conditions in January 2005 for the treatment of multiple myeloma patients who have relapsed following front-line therapy and are refractory to their most recent therapy. In 2008, VELCADE was also approved as part of combination therapy for the treatment of patients with previously untreated multiple myeloma who are unsuitable for stem cell transplantation.

"The new option of the subcutaneous delivery route has the potential for more patients to benefit from bortezomib. Patients with poor venous access will have improved convenience. For patients with pre-existing peripheral neuropathy and patients at high risk for developing peripheral neuropathy this alternate route will also result in improved safety with the reduced risk of developing worsening of neuropathy," said Dr. Kevin Song, MD, FRCPC, BC Cancer Agency, Vancouver General Hospital and the Leukemia/Bone Marrow Transplant Program of BC, Vancouver. "In addition, subcutaneous delivery of bortezomib provides physicians and patients the opportunity to tailor treatment based on individual preferences and circumstances. I have no doubt that the subcutaneous delivery route will become the preferred option."

Multiple myeloma is characterized by excessive numbers of abnormal plasma cells in the bone marrow.4 Symptoms of the disease often include bone pain, fatigue, unusual bleeding (usually from the nose and gums), frequent infections and fevers, thirst, weight loss and nausea or vomiting. Multiple myeloma may also cause structural bone damage resulting in painful fractures.5 The goal of multiple myeloma treatment is to relieve symptoms, avoid complications, and prolong life.6

"Myeloma Canada endorses Health Canada's decision to approve the subcutaneous administration of VELCADE," said Aldo Del Col, Co-Founder and Executive Director of Myeloma Canada. "From a patient perspective, subcutaneous administration may reduce the risk of neuropathy, thereby allowing patients to continue their treatment to optimize clinical outcomes."

The results of an open-label, randomized, phase III non-inferiority study1 conducted with 222 patients with relapsed multiple myeloma randomly assigned to receive subcutaneous or intravenous bortezomib found that patients receiving bortezomib subcutaneously achieved a four-cycle overall response (ORR) of 42 per cent and complete response (CR) rate of six per cent, while patients receiving bortezomib intravenously achieved an ORR of 44 per cent and a CR rate of nine per cent. The overall safety profile was similar between the two arms. However, differences were observed in the incidence of peripheral neuropathy (PN). In the subcutaneous arm of the trial, six per cent of patients experienced PN of grade three or higher, compared with 16 per cent in the intravenous arm. In the subcutaneous arm, 38 per cent of patients experienced PN of all grades, compared with 53 per cent of patients in the intravenous arm. Dose reductions occurred due to drug related adverse events in 31 per cent of patients in the subcutaneous treatment group compared with 43 per cent of the intravenously treated patients.7 In the subcutaneous treatment group, 18 per cent of patients discontinued study treatment due to a drug-related adverse event compared with 23 per cent in the intravenous treatment group.8

"This new indication further supports the efficacy of bortezomib for patients living with multiple myeloma," added Dr. Song. "In addition, subcutaneous delivery may offer greater convenience to patients and healthcare providers."

About Multiple Myeloma in Canada Multiple myeloma is the second most prevalent blood cancer after non-Hodgkin's lymphoma.9 In 2011, there were approximately 7,000 Canadians living with multiple myeloma and the prevalence in Canada continues to rise.1 According to the 2011 Canadian Cancer Statistics report released by the Canadian Cancer Society, the total new cases of multiple myeloma diagnosed annually in Canada are estimated at 2,300, with the total number of deaths from multiple myeloma estimated at 1,370 annually.8 The average age at diagnosis is 62 years for men and 61 years for women, and only four per cent of cases are diagnosed in individuals under the age of 45.11

About VELCADE(bortezomib) for Injection1 VELCADE offers a completely novel approach to treating multiple myeloma by acting on a unique target in cells called the proteasome. By blocking the proteasome, VELCADE disrupts processes related to the growth and survival of cancer cells. 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.

Excerpt from:
Health Canada approves subcutaneous administration of VELCADE®* in multiple myeloma

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