Velcade Approved for Mantle Cell Lymphoma in Europe

The European Commission approved the drug Velcade (bortezomib) for the treatment of adults with previously untreated mantle cell lymphoma (MCL).

Velcade had previously only been approved for the treatment of multiple myeloma.

This latest indication is specifically for use in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CAP, or VR-CAP when Velcade is included) in treatment-naive patients who are deemed unsuitable for a blood stem cell transplantation.

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Previous trial led to drug's approval

Approval was based on data from LYM-3002, a random and controlled Phase III trial that included 487 patients diagnosed with mantle cell lymphoma who were not eligible for a transplantation. The trial pitted VR-CAP against R-CHOP.

"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," said Thomas Stark, Janssen EMEA Vice President of Medical Affairs. "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."

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