Janssen-Cilag International NV (Janssen) announced today that the European Commission has approved a variation to the terms of the marketing authorisation of Velcade (bortezomib) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for blood stem-cell transplantation.

The decision from the European Commission follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 18 December 2014. This approval allows for the marketing of Velcade for the above indication in all 28 countries of the European Union (EU). The approval of Velcade in MCL is based on data from the Phase 3 study, LYM-3002.

In the European Union, Velcade is currently indicated for the treatment of multiple myeloma (MM), another rare blood-based cancer, either as monotherapy or in combination with other treatment regimens.

For more details, go to: http://www.investor.jnj.com/releaseDetail.cfm?releaseid=895233