Janssen receives new EU lymphoma approval for Velcade

Janssen has announced that its drug Velcade has been approved in a new mantle cell lymphoma (MCL) indication by the European Commission.

A variation to the terms of the drug's marketing authorisation will allow it to be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone in the treatment of adult patients with previously untreated MCL who are unsuitable for blood stem cell transplantation.

This new authorisation is based on positive data from the phase III trial LYM-3002, which demonstrated the significant progression-free survival benefits Velcade can offer in this indication.

Thomas Stark, vice-president for medical affairs at Janssen in Europe, the Middle East and Africa, said: "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."

Velcade is also indicated for the treatment of multiple myeloma, another rare blood-based cancer, either as monotherapy or in combination with other treatment regimens.