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FDA approves SC daratumumab + VRd for NDMM
On January 27, 2026, the U.S. Food and Drug Administration (FDA) announced approval for subcutaneous (SC) daratumumab (Dara) in combination with bortezomib + lenalidomide + dexamethasone (VRd) for the treatment of adults with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT).
The approval was supported by data from the phase III CEPHEUS trial (NCT03652064), which evaluated SC Dara + VRd (DVRd) vs VRd alone in 395 patients with NDMM (n = 197 received DVRd). The rates of measurable residual disease (MRD)-negativity were 52.3% and 34.8% in the DVRd and VRd arms, respectively (p = 0.0005). The DVRd arm also demonstrated a superior progression-free survival (PFS; hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.41–0.88; p = 0.0078); the median PFS was not reached in either cohort. In patients achieving a complete response or better (≥CR), the DVRd arm had higher rates of MRD-negativity (68.7% vs 59.5%) and sustained MRD-negativity (42.6% vs 25.3%, p = 0.0003) vs the VRd arm.
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