Janssen Pharmaceutical Companies of Johnson & Johnson has secured marketing authorization for its monoclonal antibody Darzalex (daratumumab) from the European Commission (EC) as initial therapy for adult patients with newly diagnosed multiple myeloma, who are not eligible for autologous stem cell transplant (ASCT).
The EC approval is for the use of daratumumab in combination with bortezomib, melphalan and prednisone (VMP).
Dr Catherine Taylor – Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen, commenting on daratumumab approval by the EC, 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. This is a significant step forward.”
Daratumumab approval was driven by the data collected from a phase 3 study called ALCYONE (MMY3007) in which the Janssen drug in combination with VMP decreased the risk of disease progression or death by 50%, compared to VMP monotherapy.
The median progression free survival (PFS) for daratumumab/VMP combination had not yet been reached, compared to an estimated median PFS of 18.1 months for patients who were subjected to only VMP.
Commenting on daratumumab approval by the EC, Dr Torben Plesner – the first investigator to administer daratumumab in human trials, 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.”
Daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone was previously approved in Europe for the treatment of adult patients with multiple myeloma who had at least one prior therapy.
The Janssen drug is also indicated as a monotherapy in Europe for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy had a proteasome inhibitor (PI) and an immunomodulatory agent, and who had experienced disease progression on the last therapy.