Posted by Michael Wonder on 17 Dec 2018
Health Canada approves Darzalex (daratumumab) for newly diagnosed patients with multiple myeloma who are transplant ineligible
17 December 2018 - Darzalex combination therapy significantly reduced the risk of disease progression or death compared to a preferred regimen alone.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved Darzalex (daratumumab), in combination with bortezomib, melphalan and prednisone (VMP), for the treatment of patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplantation. Darzalex is the first monoclonal antibody to be approved for newly diagnosed patients in Canada.
The Health Canada approval of Darzalex in combination with VMP is supported by data from the randomised, open-label, multi-center Phase 3 ALCYONE (MMY3007) study, published in the New England Journal of Medicine.
