European Commission Approves Darzalex SC with VRd for Newly Diagnosed Multiple Myeloma
Key Insights
The European Commission has approved Darzalex subcutaneous formulation (SC) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma (search) (NDMM) patients eligible for autologous stem cell transplant (ASCT).
The approval is based on the Phase 3 PERSEUS study, which demonstrated a 58% reduction in the risk of disease progression or death compared to VRd alone.
The Darzalex regimen led to deeper responses, with a minimal residual disease (MRD) negativity rate of 75.2%.
The European Commission (EC) has granted approval to Janssen-Cilag, a subsidiary of Johnson & Johnson, for the expanded use of Darzalex (daratumumab) subcutaneous formulation (SC) in treating specific multiple myeloma (search) patients. This approval allows for the use of Darzalex SC in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for patients newly diagnosed with multiple myeloma (NDMM) who are eligible for autologous stem cell transplant (ASCT). This decision provides these patients with access to a daratumumab SC-based quadruplet therapy right from the point of diagnosis.
Clinical Trial Data
The approval is supported by data obtained from the Phase 3 PERSEUS study, which involved 709 patients. The study evaluated the efficacy of the daratumumab SC-based quadruplet regimen for induction and consolidation therapy, followed by daratumumab SC and lenalidomide (D-R) maintenance therapy, in comparison to VRd during induction and consolidation, followed by lenalidomide (R) maintenance. After a median follow-up of 47.5 months, the PERSEUS study demonstrated a significant improvement in progression-free survival (PFS). The Darzalex regimen reduced the risk of disease progression or death by 58% compared to VRd alone. Furthermore, the regimen led to deeper responses, with an overall minimal residual disease (MRD) negativity rate of 75.2%.
Expert Commentary
Edmond Chan, Johnson & Johnson innovative medicine haematology EMEA therapeutic area lead and senior director, stated, "The European Commission’s approval of this daratumumab quadruplet regimen marks a pivotal step forward in the treatment of newly diagnosed multiple myeloma (search). By incorporating daratumumab 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."
Safety Profile and Future Plans
The overall safety profile of daratumumab-VRd was consistent with the established safety profiles of both daratumumab SC and VRd. Johnson & Johnson plans to further assess the potential of daratumumab across the entire disease spectrum of multiple myeloma (search). Janssen Biotech, also a Johnson & Johnson company, has a worldwide agreement with Genmab since August 2012, granting Johnson & Johnson a license to develop, manufacture, and commercialize daratumumab.
Johnson & Johnson recently submitted an application to the US Food and Drug Administration (FDA) for a Darzalex Faspro-based regimen for NDMM patients for whom transplant is not planned, indicating a continued effort to expand the therapeutic applications of daratumumab.