Janssen-Cilag International, part of Johnson & Johnson (J&J), has received approval from the European Commission for an expanded use of its subcutaneous formulation of DARZALEX (daratumumab).
The latest approval permits the use of daratumumab in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for treating adults newly diagnosed with multiple myeloma.
With this decision, daratumumab is now sanctioned for nine different indications in multiple myeloma, five of which are applicable in frontline settings, covering both patients eligible and ineligible for autologous stem-cell transplant (ASCT).
The recent extension follows the earlier approval of daratumumab-VRd for ASCT-eligible patients in October 2024, based on findings from the Phase 3 PERSEUS study. The study demonstrated the effectiveness of this quadruplet regimen during induction and consolidation phases, with subsequent maintenance using daratumumab SC and lenalidomide.
The expanded approval for ASCT-ineligible patients is supported by data from the Phase 3 CEPHEUS trial, which indicated a significant improvement in minimal residual disease (MRD) negativity and complete response rates when daratumumab was added to the VRd regimen.
The CEPHEUS trial was a global, open-label, randomised study assessing the efficacy and safety of daratumumab combined with VRd against VRd alone in newly diagnosed multiple myeloma patients aged 18 or older, who were either ineligible for ASCT or had no ASCT planned initially.
Key eligibility involved confirmed diagnosis, adequate organ function, and measurable disease, while excluding those with prior exposure to certain therapies or with uncontrolled conditions. Participants were assigned to receive either the daratumumab-VRd combination or VRd alone, with daratumumab administered subcutaneously as per the approved schedule.
The primary outcome measured was the overall MRD negativity rate, while secondary outcomes included sustained MRD negativity beyond 12 months, complete response rate, progression-free survival, and overall survival.
The company said safety evaluations were consistently performed, focusing on adverse effects, laboratory tests, and imaging.
