EC Approves J&J's Darzalex Regimen for New Multiple Myeloma Cases

Johnson & Johnson (J&J) has announced that the European Commission (EC) has approved a subcutaneous (SC) formulation of Darzalex (daratumumab) for the treatment of newly diagnosed multiple myeloma (NDMM). This approval includes the use of Darzalex in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for patients eligible for an autologous stem cell transplant (ASCT).

The EC's decision was based on positive results from the PERSEUS study, which involved over 700 NDMM patients eligible for ASCT. Participants were randomized to receive either Darzalex SC plus VRd during induction and consolidation therapy, followed by Darzalex SC and lenalidomide for maintenance therapy, or VRd during induction and consolidation, followed by lenalidomide maintenance. The results demonstrated that the Darzalex-based regimen reduced the risk of disease progression or death by 58% compared to VRd alone after a median follow-up of 47.5 months, and also led to deeper responses.

Multiple myeloma (MM) is a type of blood cancer that affects plasma cells, a kind of white blood cell. In 2022, over 35,000 individuals were diagnosed with MM in the European Union. While MM is currently incurable, treatments like Darzalex can significantly improve patient outcomes. Darzalex is a monoclonal antibody that targets the CD38 protein found in high levels on abnormal plasma cells. By binding to CD38, Darzalex triggers the immune system to attack and kill these abnormal cells.

Darzalex was first approved by the EC for the treatment of multiple myeloma in 2016. Since then, it has become a cornerstone in the treatment of this disease. The recent approval of the SC formulation in combination with VRd marks a significant advancement in the treatment of newly diagnosed patients. Edmond Chan, senior director and therapeutic area lead for hematology in EMEA at J&J, commented on the approval, highlighting the importance of optimizing frontline therapy to transform patient outcomes and establish new standards of care from induction through maintenance phases.

The approval of Darzalex SC comes shortly after the EC also approved two other J&J treatments: Yuvanci, a single tablet combination therapy of macitentan and tadalafil for long-term treatment of pulmonary arterial hypertension, and Rybrevant (amivantamab) as part of a combination treatment for a new subset of advanced lung cancer patients.

These recent approvals underscore J&J's commitment to developing innovative treatments that address significant unmet medical needs across various therapeutic areas. The company continues to advance its pipeline and expand the use of its existing therapies to improve patient care and outcomes.