European Commission Approved Subcutaneous DARZALEX® (daratumumab)-based Quadruplet Regimen for the Treatment of Patients with Newly Diagnosed Multiple Myeloma, Regardless of Transplant Eligibility

On April 9, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval for an indication extension of DARZALEX (daratumumab) subcutaneous (SC) co-formulated with ENHANZE in the frontline setting (Press release, Halozyme, APR 9, 2025, View Source [SID1234651857]). The approval is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma.1

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"The continued expansion of DARZALEX delivered subcutaneously with ENHANZE into additional settings highlights its status as a cornerstone of therapy for multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme. "This approval means that newly diagnosed patients can receive daratumumab subcutaneous plus VRd and avoid the need for lengthy IV infusions."

This approval follows the indication extension approval for daratumumab-VRd in October 2024, for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant, based on the results from the Phase 3 PERSEUS (NCT03652064) study. The study evaluated this daratumumab SC-based quadruplet regimen for induction and consolidation therapy, followed by daratumumab SC and lenalidomide maintenance.2,3

1 European Medicines Agency. DARZALEX (daratumumab) Summary of Product Characteristics. April 2025.

2 Rodríguez-Otero P, et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): Analysis of minimal residual disease (MRD) in the PERSEUS trial. 2024 American Society for Clinical Oncology Annual Meeting. June 3, 2024.

3 Johnson & Johnson Innovative Medicine EMEA. DARZALEX (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible. Available at: View Source Last accessed: April 2025.