European Commission Approves J&J's Darzalex Regimen for Newly Diagnosed Multiple Myeloma
Key Insights
The European Commission has approved Johnson & Johnson's Darzalex subcutaneous formulation for newly diagnosed multiple myeloma (search) (NDMM).
Darzalex, combined with bortezomib, lenalidomide, and dexamethasone (VRd), is authorized for NDMM patients eligible for autologous stem cell transplant (ASCT).
The approval was based on the PERSEUS study, which showed a 58% reduction in disease progression or death compared to VRd alone.
The European Commission (EC) has granted approval to Johnson & Johnson's (J&J) subcutaneous (SC) formulation of Darzalex (daratumumab) for use in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of newly diagnosed multiple myeloma (search) (NDMM) in patients eligible for autologous stem cell transplant (ASCT). This decision marks a significant advancement in the treatment landscape for this patient population.
The approval is based on the positive results of the Phase 3 PERSEUS study, a randomized trial involving over 700 ASCT-eligible NDMM patients. The study compared the Darzalex SC plus VRd regimen as induction and consolidation therapy, followed by Darzalex SC and lenalidomide maintenance, against VRd induction and consolidation followed by lenalidomide maintenance.
Significant Reduction in Disease Progression
The Darzalex-based regimen demonstrated a significant reduction in the risk of disease progression or death by 58% compared to VRd alone (p<0.0001) after a median follow-up of 47.5 months. The study also showed that the Darzalex combination led to deeper responses, indicating a more effective eradication of myeloma cells.
Mechanism of Action and Clinical Impact
Darzalex is a monoclonal antibody designed to target the CD38 (search) protein, which is highly expressed on multiple myeloma (search) cells. By binding to CD38, Darzalex activates the immune system to eliminate these abnormal white blood cells. This targeted approach has proven effective in improving outcomes for patients with multiple myeloma.
Edmond Chan, Senior Director, EMEA Therapeutic Area Lead Haematology, Innovative Medicine, J&J, stated, "The EC’s approval of this [Darzalex] quadruplet regimen marks a pivotal step forward in the treatment of NDMM. By incorporating [Darzalex] SC into this regimen we are further optimising frontline therapy for patients, building on our aim to transform outcomes, and establish new standards of care for eligible patients from induction through to maintenance."
Multiple Myeloma Burden
In 2022, over 35,000 individuals in the EU were diagnosed with multiple myeloma (search), an incurable blood cancer affecting plasma cells. This approval offers a new, more effective treatment option for these patients, potentially improving their quality of life and extending survival.