FDA Approves Subcutaneous Daratumumab Combination in NDMM

The FDA has approved subcutaneous daratumumab and hyaluronidase-fihj (Darzalex Faspro) plus bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (VRd) among adult patients with newly diagnosed multiple myeloma (NDMM) who cannot undergo autologous stem cell transplant (ASCT), according to an announcement from the agency.¹

Supporting data for the approval came from the phase 3 CEPHEUS trial (NCT03652064), in which investigators assessed the daratumumab-based combination (n = 197) vs VRd alone (n = 198) among those with NDMM.² Topline data revealed a minimal residual disease (MRD) negativity rate of 52.3% in the daratumumab arm vs 34.8% in the VRd arm (P = .0005). The daratumumab regimen also conferred a progression-free survival (PFS) improvement (HR, 0.60; 95% CI, 0.41-0.88; P = .0078).

Regarding safety, the regimen’s prescribing information details warnings and precautions for hypersensitivity, other administration reactions, infections, neutropenia, thrombocytopenia, and embryo-fetal toxicity interference associated with cross-matching and red blood cell antibody screening.

The agency approved a recommended dose of 1800 mg of daratumumab per 30,000 units of hyaluronidase in combination with VRd.

References

1. FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma. News release. FDA. January 27, 2026. Accessed January 27, 2026. https://tinyurl.com/47r6r8xf
2. A study comparing daratumumab, VELCADE (bortezomib), lenalidomide, and dexamethasone (D-VRd) with VELCADE, lenalidomide, and dexamethasone (VRd) in participants with untreated multiple myeloma and for whom hematopoietic stem cell transplant is not planned as initial therapy. ClinicalTrials.gov. Updated January 20, 2026. Accessed January 27, 2026. https://tinyurl.com/ycyy6cu4