On July 30, 2024 the US Food and Drug Administration approved the four-drug regimen of subcutaneous daratumumab (daratumumab and hyaluronidase-fihj), bortezomib, lenalidomide, and dexamethasone as induction and consolidation therapy in patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.
The approval was based on the phase 3 PERSEUS study of 709 patients which compared the four-drug regimen to standard treatment with bortezomib, lenalidomide, and dexamethasone. The addition of daratumumab led to better progression-free survival at 48 months (84% vs 68%; hazard ratio [HR]=0.42 ; P<.001), higher rates of complete response or better (88% vs 70%; P<.0010), and more patients being negative for measurable residual disease (75% vs 48%, P<.001).
peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash were the most common any grade adverse events. Neutropenia and thrombocytopenia, occurring in 62% and 29% of patients on quad therapy, respectively, were the most common grade 3 or 4 adverse events.
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