Daratumumab and Hyaluronidase-fihj With VRd Approved by FDA for Multiple Myeloma

By: JNCCN 360 Staff
Posted: Thursday, August 1, 2024

On July 30, 2024, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody daratumumab and the endoglycosidase hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for induction and consolidation therapies in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

This approval is based on the results of the randomized, open-label PERSEUS trial. In this study, a total of 709 patients (aged 70 or younger) were randomly assigned to receive either daratumumab and hyaluronidase plus VRd (n = 355) or VRd alone (n = 354). An improvement in progression-free survival was demonstrated with daratumumab and hyaluronidase plus VRd vs VRd alone; the median progression-free survival had not been reached in either arm. In the arm including daratumumab, the risk of disease progression or death was reduced by 60% vs VRd alone (hazard ratio = 0.40; 95% confidence interval = 0.29–0.57; P < .0001).

The most common adverse reactions with the daratumumab-based regimen (≥ 20%) were peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.

The recommended dose of daratumumab and hyaluronidase is 1,800 mg/30,000 units (1,800 mg of daratumumab and 30,000 units of hyaluronidase). See the prescribing information for the dosage recommendations for the other drugs.

U.S. Food & Drug Administration

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