On July 30, 2024, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Research & Development, LLC) 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).
Full prescribing information for Darzalex Faspro will be posted on Drugs@FDA.
Efficacy and Safety
Efficacy was evaluated in PERSEUS (NCT03710603), an open-label, randomized, active-controlled trial in patients with newly diagnosed multiple myeloma eligible for ASCT. Enrollment was limited to patients 70 years of age and younger. A total of 709 patients were randomized: 355 to the Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone (Darzalex Faspro-VRd) arm and 354 to the bortezomib, lenalidomide, and dexamethasone (VRd) arm.
The major efficacy outcome measure was progression-free survival (PFS) as assessed by an independent review committee based on International Myeloma Working Group (IMWG) response criteria. PERSEUS demonstrated an improvement in PFS in the Darzalex Faspro-VRd arm as compared to the VRd arm; the median PFS had not been reached in either arm. Treatment with Darzalex Faspro-VRd resulted in a reduction in the risk of disease progression or death by 60% compared to VRd alone (HR [95% CI]: 0.40 [0.29, 0.57]; p-value < 0.0001).
The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.
The recommended Darzalex Faspro 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.
Expedited Programs
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
This application was granted priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
