Marketing authorisation for Darzalex (daratumumab), from the Janssen Pharmaceutical Companies of Johnson & Johnson, to be used as a frontline treatment for newly diagnosed patients with multiple myeloma has been granted by the European Commission.
Multiple myeloma
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).
“[This] 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,” said Dr Torben Plesner, the first investigator to administer daratumumab in human trials and professor, head of the Department of Hematology at Vejle Hospital, Denmark. “I am proud that patients across Europe now have the option to use a monoclonal antibody as an initial therapy.”
“We are incredibly grateful to the patients and physicians who participated in the clinical programme for making this approval possible,” added Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen. “Our mission has been to ensure daratumumab reaches as many eligible patients as possible and to prolong and improve their quality of life. This is a significant step forward.”
The approval was based on results from the randomised, open-label, multicentre Phase III ALCYONE (MMY3007) study, which were published in the New England Journal of Medicine. In this study, when daratumumab was used in combination with VMP is reduced the risk of disease progression or death by 50% compared to treatment with VMP alone.