July 2024: The Food and Drug Administration (FDA) has granted approval for the use of daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Research & Development, LLC) in conjunction with bortezomib, lenalidomide, and dexamethasone for the purpose of inducing and consolidating treatment in patients who have recently been diagnosed with multiple myeloma and are suitable candidates for autologous stem cell transplant (ASCT).
Safety and Efficacy
The efficacy of the treatment was assessed in the PERSEUS (NCT03710603) experiment. This trial was open-label, randomized, and included patients with newly diagnosed multiple myeloma who were eligible for autologous stem cell transplantation (ASCT). Enrollment was restricted to individuals who were 70 years old or younger.
There were a total of 709 patients who were randomly assigned to two different treatment groups: 355 patients received Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone (referred to as Darzalex Faspro-VRd), and 354 patients received only bortezomib, lenalidomide, and dexamethasone (referred to as VRd).
The primary measure of effectiveness was progression-free survival (PFS), which was evaluated by an independent review committee using the response criteria established by the International Myeloma Working Group (IMWG). In the PERSEUS study, the Darzalex Faspro-VRd treatment showed a significant increase in progression-free survival (PFS) compared to the VRd treatment.
The median PFS was not determined in either treatment arm. Treating patients with Darzalex Faspro-VRd reduced the risk of disease progression or death by 60% compared to using VRd alone. The hazard ratio (HR) was 0.40 with a 95% confidence interval (CI) of 0.29 to 0.57. The p-value was less than 0.0001.
The predominant side effects (≥20%) observed were peripheral neuropathy, tiredness, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, sleeplessness, and rash.
The suggested dosage for Darzalex Faspro is 1,800 mg of daratumumab and 30,000 units of hyaluronidase, totaling 1,800 mg/30,000 units. Refer to the prescribing material to obtain the recommended dosage for the other medications.
