Velcade bortezomib regulatory update

EMA said Johnson & Johnson's Janssen-Cilag International N.V. subsidiary withdrew an application to extend the label for Velcade bortezomib to include use in combination with rituximab to treat relapsed follicular non-Hodgkin's lymphoma (NHL). According to the agency, the subsidiary said it decided to withdraw the application after EMA's CHMP indicated that data in the application did not support a positive benefit-risk balance. A spokesperson for Janssen-Cilag declined to comment on next steps. ...