By Fineline Cube 
Johnson & Johnson (J&J, NYSE: JNJ) announced that it has received clearance from the European Commission (EC) for an indication extension of Darzalex (daratumumab) subcutaneous (SC) formulation. The approval allows the drug to be used in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM).
Mechanism of Action
Daratumumab is a CD38-directed monoclonal antibody that binds with high affinity and specificity to CD38, a protein highly expressed on malignant plasma cells in multiple myeloma. This binding triggers tumor cell death through immune-mediated mechanisms such as complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and apoptosis.
Clinical Trial Results
The approval is supported by results from the Phase III CEPHEUS study, which demonstrated that the daratumumab-VRd regimen significantly reduced the risk of progression or death by 43% compared to the VRd regimen. The median progression-free survival (PFS) was not reached for the daratumumab-VRd group versus 52.6 months for the VRd group. Overall survival data remain immature, indicating the study is ongoing and final outcomes are pending.
SC Formulation Benefits
The subcutaneous formulation of daratumumab addresses the lengthy administration time and treatment burden associated with intravenous infusion. This advancement enhances patient convenience and tolerability, making the treatment more accessible and manageable for patients.-Fineline Info & Tech