On July 30, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).
PERSEUS
Efficacy was evaluated in PERSEUS (ClinicalTrials.gov identifier NCT03710603), an open-label, randomized, active-controlled trial in patients with newly diagnosed multiple myeloma eligible for ASCT. Enrollment was limited to patients aged 70 years and younger. A total of 709 patients were randomly assigned: 355 to the daratumumab and hyaluronidase-fihj with VRd arm and 354 to the VRd alone arm.
The major efficacy outcome measure was progression-free survival as assessed by an independent review committee based on International Myeloma Working Group response criteria. PERSEUS demonstrated an improvement in progression-free survival in the daratumumab and hyaluronidase-fihj with VRd arm as compared to the VRd alone arm; the median progression-free survival had not been reached in either arm. Treatment with daratumumab and hyaluronidase-fihj with VRd resulted in a reduction in the risk of disease progression or death by 60% compared to VRd alone (hazard ratio = 0.40, 95% confidence interval = 0.29–0.57, P < .0001).
The most common adverse reactions occurring in ≥ 20% of patients taking daratumumab and hyaluronidase-fihj with VRd were peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.
The recommended daratumumab and hyaluronidase-fihj dose is 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase). See the prescribing information for the dosage recommendations for the other drugs.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was also granted Priority Review.
