Johnson & Johnson pulls EU submission for Velcade use in NHL

The European Medicines Agency has been formally notified by US health care giant Johnson & Johnson’s (NYSE: JNJ) European subsidiary Janssen-Cilag International of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorized drug Velcade (bortezomib).

On September 2, 2011, Janssen-Cilag submitted an application to extend the marketing authorization for Velcade in combination with rituximab for the treatment of patients with relapsed follicular non-Hodgkin's lymphoma. At the time of the withdrawal the application was under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Velcade was first authorized in the European Union in 2004 and is indicated in combination with melphalan and prednisone to treat patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with a bone-marrow transplant. Velcade is also indicated as monotherapy to treat progressive multiple myeloma in patients who have received at least one prior therapy and have already had or are unsuitable for a bone-marrow transplant. Global sales of Velcade in the first quarter of 2012 rose 26.1% year-on-year to $353 million.