J&J Seeks EMA Approval For DARZALEX Quadruplet Therapy For Multiple Myeloma

(RTTNews) - Janssen-Cilag International NV, a Johnson & Johnson company (JNJ), announced Wednesday the submission of a Type II variation application to the European Medicines Agency (EMA).

The submission is seeking approval for an indication extension of 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, evaluating D-VRd induction and consolidation therapy, ASCT, and daratumumab with lenalidomide (D-R) maintenance therapy, compared to VRd, ASCT and R maintenance.

The 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, compared to the control arm.