FDA approves subcutaneous daratumumab in combination with VRd for NDMM

On July 30, 2024, the U.S. Food and Drug Administration (FDA) approved subcutaneous daratumumab (D) in combination with bortezomib (V), lenalidomide (R), and dexamethasone (d) as induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.¹

This approval was based on data from the phase III PERSEUS trial. The Multiple Myeloma Hub has previously reported on the primary safety and efficacy data from the PERSEUS trial (NCT03710603).¹

PERSEUS pivotal data¹

• In total, 709 patients were randomized 1:1 to receive D-VRd (n = 355) or VRd (n = 354).
• Treatment with D-VRd resulted in a significantly higher progression-free survival (PFS) rate compared with VRd alone, with a hazard ratio of 0.4 (95% confidence interval [CI], 0.29–0.57; p < 0.0001).
• Median PFS was not reached in either treatment arm.
• With a median follow-up of 47.5 months, the 18-month estimated PFS rates were 84.3% and 67.7% in the D-VRd and VRd arm, respectively.
• The most common toxicities experienced by ≥20% of patients treated in the D-VRd arm included peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory tract infections, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.