European Commission approves added indication for Janssen’s Velcade, in MCL

6 February 2015

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag International NV (Janssen) has received approval from the European Commission for a variation to the terms of the marketing authorization 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 European Medicines agency’s Committee for Medicinal Products for Human Use (CHMP) in December 2014.This approval allows for the marketing of Velcade for the above indication in all 28 countries of the European Union. The approval of Velcade in MCL is based on data from the Phase III study, LYM-3002.

Velcade already approved for MCL, generating blockbuster sales

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