J&J Submits For EMA Approval For DARZALEX SC Quadruplet Regimen In Newly Diagnosed Multiple Myeloma

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

This submission is supported by data from the Phase 3 CEPHEUS study, which showed 60.9 percent of patients achieved minimal residual disease (MRD)-negativity with D-VRd and the risk of progression or death was reduced by 43 percent.

The CEPHEUS study (NCT03652064), evaluated the efficacy and safety of D-VRd compared to VRd for NDMM patients who are transplant ineligible or for whom ASCT was not planned as initial therapy.