▎WuXiEdited by Kant Content Team

Johnson & Johnson announced the other day that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommendedExpand the indications for Darzalex (daratumumab) subcutaneous injection (SC) formulation, using subcutaneous Darzalex in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the first-line treatment of newly diagnosed adult patients with multiple myeloma.

The CHMP's recommendation is based on data from the phase 3 clinical trial CEPHEUS, which evaluated the efficacy and safety of D-VRd compared to bortezomib, lenalidomide, and dexamethasone (VRd) in patients who are not eligible for transplant or do not plan to undergo autologous stem cell transplantation (ASCT) as part of their initial treatment. The study data were previously presented at the 2024 International Myeloma Society (IMS) Annual Meeting and the 2024 American Society of Hematology (ASH) Annual Meeting.

Data analysis published in October 2024 showed that, at a median follow-up of 58.7 months,Compared with VRd, the D-VRd regimen increases the depth and durability of patients' responses. In the D-VRd group, 60.9% of patients achieved minimal residual disease (MRD) negativity, compared to 39.4% in the VRd group (P<0.0001).The study also showed that, compared with VRd, D-VRd significantly reduced the risk of disease progression or death by 43% (HR=0.57, 95% CI: 0.41-0.79, P<0.0005), andThe complete response rate (CR) was higher in the D-VRd group at 81.2%, compared to 61.6% in the VRd group (P<0.0001).The overall safety of D-VRd is consistent with the known safety profiles of Darzalex subcutaneous injection and VRd.

Darzalex Subcutaneous Injection, jointly developed by Johnson & Johnson and Genmab, is the first anti-CD38 antibody that can be administered via subcutaneous injection, reducing the treatment time for patients from several hours to just a few minutes.It has been approved for eight indications in multiple myeloma, four of which are for frontline treatment.

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