Johnson & Johnson, through its subsidiary Janssen-Cilag International NV, has submitted a Type II variation application to the European Medicines Agency (EMA) for the approval of DARZALEX (daratumumab) in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant. The submission is based on the Phase 3 PERSEUS study results, which showed significant improvement in progression-free survival and response rates compared to the control arm. Daratumumab is a foundational therapy in multiple myeloma treatment, approved in eight indications, and has been used in over 484,000 patients worldwide.