Janssen secures EC approval for daratumumab as new multiple myeloma therapy

The Janssen Pharmaceutical Companies of Johnson & Johnson have achieved a significant milestone with the European Commission’s approval of Darzalex (daratumumab) for use as an initial therapy in adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). This approval allows for the combination of daratumumab with bortezomib, melphalan, and prednisone (VMP), offering a new hope for patients across Europe.

The approval was largely influenced by the results from the phase 3 ALCYONE (MMY3007) study, which demonstrated that the combination of daratumumab with VMP reduced the risk of disease progression or death by 50% compared to VMP alone. Notably, the median progression-free survival (PFS) for the daratumumab/VMP combination has not yet been reached, providing a stark contrast to the 18.1 months median PFS for patients treated solely with VMP.

Dr. Catherine Taylor, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead at Janssen, expressed gratitude to the patients and physicians involved in the clinical program: “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.”

Dr. Torben Plesner, the first investigator to administer daratumumab in human trials, highlighted the importance of this approval: “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.”

Previously, daratumumab had been approved in combination with other drugs like lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who had received at least one prior therapy. The drug is also indicated as a monotherapy for patients with relapsed and refractory multiple myeloma.

The European Commission’s approval of daratumumab as an initial therapy marks a pivotal advancement in the treatment of multiple myeloma, promising improved outcomes for patients facing this challenging disease.