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.
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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.