EC Approves J&J's Subcutaneous Darzalex for Newly Diagnosed Multiple Myeloma

Johnson & Johnson (J&J) has announced that the European Commission (EC) has granted approval for its subcutaneous formulation of Darzalex (daratumumab) in a quadruplet regimen for treating newly diagnosed multiple myeloma (MM). This approval allows the combination of Darzalex with bortezomib, lenalidomide, and dexamethasone (VRd) to be used as a first-line treatment, irrespective of whether patients are eligible for a transplant. In 2022, over 35,000 individuals in the EU were diagnosed with MM, a type of blood cancer that currently has no cure.

Darzalex, a monoclonal antibody, functions by binding to the CD38 protein, which is highly expressed on malignant white blood cells in multiple myeloma, thereby inhibiting tumor growth. The drug has received authorization for nine different indications related to multiple myeloma, including those involving newly diagnosed patients who can or cannot undergo autologous stem-cell transplant (ASCT).

The EC's recent decision was influenced by a recommendation from the European Medicines Agency’s committee on human medicines and was backed by favorable outcomes from the phase 3 CEPHEUS study. This study compared the efficacy of the Darzalex SC-VRd regimen with VRd alone in newly diagnosed patients who were either ineligible for transplant or for whom ASCT was not initially planned.

With a median follow-up period of 59 months, the primary endpoint of the study was achieved, demonstrating a minimal residual disease (MRD)-negativity rate of 60.9% for patients treated with Darzalex SC-VRd, compared to 39.4% for those in the VRd group. Furthermore, the percentage of patients achieving sustained MRD-negativity for at least 12 months was nearly double in the Darzalex group at 48.7%, compared to 26.3% in the VRd group. The Darzalex-based regimen also significantly enhanced the depth of response, with higher rates of complete response or better being observed.

The quadruplet regimen showed a 43% reduction in the risk of disease progression or death. Additionally, the overall safety profile for the Darzalex SC-VRd combination was in line with the known safety data for both Darzalex SC and VRd.

Jordan Schecter, Vice President and Disease Area Leader for multiple myeloma at J&J Innovative Medicine, described the EC's approval as a pivotal achievement. He emphasized that this authorization allows all patient groups, regardless of age, fitness, or risk level, access to a Darzalex-based triplet or quadruplet regimen as an initial treatment option. Schecter noted that this is an essential milestone towards the overarching aim of achieving a functional cure for multiple myeloma.