FX.co ★ J&J Seeks EMA Approval For DARZALEX Quadruplet Therapy For Multiple Myeloma

Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, has announced the submission of a Type II variation application to the European Medicines Agency (EMA). The application seeks to extend the approved uses of DARZALEX (daratumumab) to subcutaneous administration with bortezomib, lenalidomide, and dexamethasone for treating adult patients newly diagnosed with multiple myeloma, who qualify for autologous stem cell transplant.

This proposal to the EMA is substantiated by data procured from the Phase 3 PERSEUS study, investigating D-VRd induction and consolidation therapy, Autologous Stem Cell Transplant, and daratumumab in combination with lenalidomide maintenance treatment, in contrast with VRd, Autologous Stem Cell Transplant and R maintenance.

The analysis revealed that the primary endpoint of progression-free survival was met by the study, displaying a significant 58% decrease in the risk of disease advancement or death during a median follow-up of 47.5 months, as compared to the control group.