Janssen submit in EMA Darzalex subcutaneous formulation for quadruplet therapy in newly diagnosed multiple myeloma

Janssen has announced the submission of an extension of indication appliation for Darzalex (daratumumab) subcutaneous (SC) formulation in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). 

The submission to the EMA is supported by data from the Phase 3 PERSEUS (NCT03710603) study,2 evaluating D-VRd induction and consolidation therapy, ASCT, and daratumumab with lenalidomide (D-R) maintenance therapy, compared to VRd, ASCT and R maintenance.

Results from the primary analysis showed that the study met its primary endpoint of progression-free survival (PFS), with a significant reduction in the risk of disease progression or death of 58 percent at a median follow-up of 47.5 months (Hazard Ratio [HR], 0.42; 95 percent Confidence Interval [CI] 0.30-0.59; P<0.0001), compared to the control arm.

Reference link: Janssen press release