The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that the European Commission (EC) has granted marketing authorisation for Darzalex® (daratumumab) for use as frontline therapy. The approval is for the use of daratumumab in combination with bortezomib, melphalan and prednisone (VMP), for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
The approval is based on results from the randomised, open-label, multicentre Phase 3 ALCYONE (MMY3007) study, published in the New England Journal of Medicine earlier this year. Daratumumab in combination with VMP reduced the risk of disease progression or death by 50 percent, compared to treatment with VMP alone. The median progression free survival (PFS) for daratumumab-VMP had not yet been reached, compared to an estimated median PFS of 18.1 months for patients who received VMP alone.
“I am proud that patients across Europe now have the option to use a monoclonal antibody as an initial therapy.”
Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells. MM is the second most common form of blood cancer, with around 40,570 new cases in Europe in 2015. The most recent five-year survival data for 2000-2007 show that across Europe, up to half of newly diagnosed patients do not reach five-year survival. Almost 29% of patients with MM will die within one year of diagnosis. Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.
Dr Torben Plesner, MD, the first investigator to administer daratumumab in human trials and Professor, Head of the Department of Hematology at Vejle Hospital, Denmark said, “Today’s approval is extremely important for multiple myeloma patients, as providing a frontline treatment option that demonstrates a deep and durable response often provides the best chance at lasting remission. It’s all the more remarkable considering it has only been ten years since the first dose of daratumumab was administered in the earliest human studies. I am proud that patients across Europe now have the option to use a monoclonal antibody as an initial therapy.”
Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen said, “We are incredibly grateful to the patients and physicians who participated in the clinical programme for making this approval possible. Our mission has been to ensure daratumumab reaches as many eligible patients as possible and to prolong and improve their quality of life.”