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EC approves Velcade label update

The European Commission has approved a label update for Velcade to include survival benefit in untreated patients with multiple myeloma

Following a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) - the scientific committee of the European Medicines Agency (EMA) - the European Commission has approved an update to the Summary of Product Characteristics (SmPC) for Velcade (bortezomib) to include survival benefit in previously untreated patients with multiple myeloma.

The pharmacological properties section of the SmPC for bortezomib now includes updated efficacy results based on clinical evidence from a prospectively defined survival update of the phase III international VISTA (Velcade as Initial Standard Therapy in Multiple Myeloma) study.

The study showed a significantly improved overall survival of 68.5 per cent for patients treated with bortezomib plus melphalan and prednisone (Vc+M+P), compared to 54 per cent (p=0.0008) for patients on melphalan and prednisone (M+P) alone after three years of treatment. It also demonstrated a significantly higher complete response rate of 30 per cent for Vc+M+P versus 4 per cent for M+P alone.

Velcade treats multiple myeloma, the second most common haematologic malignancy, by reversibly interrupting the normal working of cell proteasomes causing myeloma cancer cells to stop growing and die. It is licensed for use in combination with melphalan and prednisone in previously untreated patients with multiple myeloma (ie the front line setting) who are ineligible for high-dose chemotherapy and bone marrow transplant. Traditionally, multiple myeloma is associated with a poor prognosis, with a median survival of three to five years from diagnosis.

17th June 2010

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