European regulators have expanded the label on Johnson & Johnson’s multiple myeloma drug Velcade to cover mantle cell lymphoma.
Specifically, the European Commission has approved a variation to the terms of J&J unit Janssen’s marketing authorisation of Velcade (bortezomib) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for adults with previously-untreated MCL who are unsuitable for blood stem-cell transplantation. The drug is currently indicated in Europe for multiple myeloma, either as monotherapy or in combinations.
Thomas Stark, head of medical affairs at Janssen Europe, Middle East and Africa, noted that “we already offer Imbruvica (ibrutinib) as a second-line treatment in MCL and are pleased to be able to provide additional treatment options for this disease”. Velcade is already approved for MCL in the USA, marketed by Takeda’s Millennium unit.
