Johnson & Johnson's DARZALEX® (daratumumab) subcutaneous-based regimen receives positive CHMP opinion for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility

Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of daratumumab subcutaneous (SC) formulation for newly diagnosed multiple myeloma (NDMM), which would make it the only anti-CD38 therapy available for all patient types in the frontline setting [1][2][5]. Group 1: Company Developments - Janssen-Cilag International NV, a Johnson & Johnson company, announced the CHMP's positive recommendation for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone for adult patients with NDMM [1][5]. - The recommendation is based on the results from the Phase 3 CEPHEUS study, which demonstrated improved progression-free survival for patients receiving daratumumab-VRd compared to standard VRd [1][2][5]. - Daratumumab has been a foundational therapy in multiple myeloma treatment, with over 618,000 patients treated globally since its launch [5][6]. Group 2: Study Insights - The CEPHEUS study (NCT03652064) is an international, randomized, open-label Phase 3 trial that enrolled 395 patients with NDMM who were ineligible for stem cell transplantation [2][5]. - The primary endpoint of the study was the overall Minimal Residual Disease (MRD) negativity rate, with a median patient age of 70 years [2][5]. - Results from the CEPHEUS study were presented at the 2024 International Myeloma Society Annual Meeting and the 2024 American Society of Hematology Annual Meeting [1][2]. Group 3: Product Information - Daratumumab is the only CD38-directed antibody approved for subcutaneous administration in multiple myeloma treatment [5][6]. - The drug works by binding to CD38, a surface protein present on myeloma cells, inhibiting tumor cell growth and causing myeloma cell death [5][6]. - Data from ten Phase 3 clinical trials have shown significant improvements in progression-free survival and/or overall survival with daratumumab-based regimens [5][6].