Janssen-Cilag / Ortho Biotech, the biopharmaceutical division of Janssen-Cilag, announced the European Commission’s approval of VELCADE in combination with melphalan and prednisone for the treatment of patients with previously untreated multiple myeloma (MM) who are not eligible for high-dose chemotherapy with bone marrow transplant.

In more than 87 countries worldwide, VELCADE monotherapy had already been approved for the treatment of relapsed and / or refractory MM in patients who have received at least one prior therapy.

“VELCADE has already made an important contribution for patients with multiple myeloma at first relapse,” said Professor Jesus San Miguel, M.D., University of Salamanca in Spain, the principal investigator for the VISTA trial. “The marketing authorisation from the EMEA is encouraging as it suggests that more patients may benefit from earlier treatment.”

The frontline 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 (CR) rates were similar to those that have been achieved in the transplant setting.

Notes

- Multiple myeloma (MM) is the second most common blood cancer, representing approximately one percent of all cancers and two percent of all cancer deaths(i).

- In 2002, there were approximately 85,700 cases of MM worldwide(ii).

- Only 30 percent of MM patients survive longer than five years(iii), with more than 18,000 people in the European Union dying each year from the disease(iv).