EC approves expanded indication for Velcade

US health care major Johnson & Johnson's multiple myeloma drug Velcade (bortezomib) has been approved by the European Commission for use in combination with melphalan and prednisone for the treatment of patients with previously-untreated MM who are not eligible for high-dose chemotherapy with bone marrow transplant.

In more than 87 countries worldwide, Velcade monotherapy has already been approved for the treatment of relapsed and/or refractory MM in patients who have received at least one prior therapy. In second-quarter 2008, global sales of the drug grew 5.9% year-on-year to $205.0 million.

The front-line approval is based on Phase III results from the VISTA trial, recently published in the New England Journal of Medicine, which demonstrated statistically-superior results across all efficacy endpoints compared to melphalan and prednisone. In particular, complete response rates were similar to those that have been achieved in the transplant setting, the firm said.