Velcade was approved for use in combination with rituximab, cyclophosphamide, doxorubicin and prednisone to treat MCL patients who are unsuitable for blood stem-cell transplantation.
Currently, Velcade is indicated for the treatment of multiple myeloma (MM) in the European Union (EU).
Janssen EMEA vice-president Medical Affairs Thomas Stark said: "We are delighted that the European Commission has approved extending the indications for use of Velcade to include first-line therapy for patients with mantle cell lymphoma.
"We already offer Imbruvica as a second-line treatment in MCL and are pleased to be able to provide additional treatment options for this disease to patients and physicians."
The approval is based on data from the randomized, open-label, active-controlled, multicenter, international, prospective Phase III trial, LYM-3002.
The trial included 487 patients with newly diagnosed MCL who were ineligible, or not considered, for bone marrow transplantation.
The results showed significant benefits when treating MCL patients using a Velcade-based combination (VR-CAP), compared to a widely used standard of care combination (R-CHOP[†]) that did not include Velcade.
Image: European Commission approves additional indication of Janssen’s Velcade to treat adults with previously-untreated MSL. Photo: courtesy of Baitong333/ FreeDigitalPhotos.net.