FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for multiple myeloma
Regulatory approval: On July 30, 2024, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The decision was supported by the phase 3 PERSEUS trial, which showed improved progression-free survival vs VRd alone (HR 0.40; p<0.0001), with median PFS not reached in either arm.
FDA approval (2024-07-30)
The FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Research & Development, LLC) with bortezomib, lenalidomide, and dexamethasone (VRd) for induction and consolidation in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant (ASCT).
Supporting evidence
Efficacy and safety were evaluated in PERSEUS (NCT03710603), an open-label, randomized, active-controlled trial enrolling patients with newly diagnosed multiple myeloma eligible for ASCT; enrollment was limited to patients ≤70 years.
- Randomized: 709 patients (Darzalex Faspro-VRd, n=355; VRd, n=354)
- Primary efficacy endpoint: progression-free survival (PFS) per independent review committee using IMWG criteria
- Result: improved PFS with Darzalex Faspro-VRd vs VRd; median PFS not reached in either arm
- Effect size: 60% reduction in risk of progression or death (HR 0.40, 95% CI 0.29–0.57; p<0.0001)
Safety and dosing (selected)
Most common adverse reactions (≥20%): peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, rash.
Recommended Darzalex Faspro dose: 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase). The application received priority review.