EC approves subcutaneous daratumumab in combination with VRd for NDMM regardless of transplant eligibility

The D-VRd regimen achieved a significantly higher minimal residual disease-negativity rate (sensitivity of 10−5) vs VRd (60.9% vs 39.4%; p < 0.0001). 

The proportion of patients achieving sustained minimal residual disease-negativity for ≥12 months was almost double with D-VRd vs VRd (48.7% vs 26.3%; p < 0.0001). 

The D-VRd regimen resulted in a higher complete response rate vs VRd (81.2% vs 61.6%; p < 0.0001). 

D-VRd significantly reduced the risk of progression or death by 43% compared to VRd (p < 0.0005), with the median progression-free survival not reached for D-VRd vs 52.6 months for VRd. 

The safety profile of D-VRd was consistent with known profiles, with the most common (>10%) Grade 3/4 hematologic and non-hematologic adverse events being neutropenia (44.2% vs 29.7%), thrombocytopenia (28.4% vs 20.0%), anemia (13.2% vs 11.8%), peripheral neuropathies (8.1% vs 8.2%), diarrhea (12.2% vs 9.2%), and COVID-19 (11.2% vs 4.6%) for D-VRd vs VRd, respectively.