FDA Approves Frontline Daratumumab and Hyaluronidase With Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma

On July 30, 2024, the US Food and Drug Administration (FDA) granted approval to daratumumab and hyaluronidase combined with bortezomib, lenalidomide, and dexamethasone for induction and consolidation for patients with newly diagnosed multiple myeloma (MM) who are eligible for autologous stem cell transplant (ASCT).

Study investigators analyzed efficacy in the an open-label, randomized, active-controlled PERSEUS trial, which included 709 patients with newly diagnosed MM who were eligible for ASCT. Enrollment was limited to patients 70 years of age and younger. 355 patients were randomized to daratumumab and hyaluronidase (Darzalex Faspro) with bortezomib, lenalidomide, and dexamethasone (Darzalex Faspro-VRd) arm and 354 were randomized to the bortezomib, lenalidomide, and dexamethasone (VRd) arm.

Progression-free survival (PFS) as the primary outcome was assessed by an independent review committee based on International Myeloma Working Group (IMWG) response criteria. Results from the PERSEUS trial demonstrated an improvement in PFS in the Darzalex Faspro-VRd arm as compared to the VRd arm, while 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 (hazard ratio [HR], 95%; confidence interval [CI], 0.40, 0.29 to 0.57]; p-value < 0.0001).

As for treatment-related adverse events, the most commonly observed reactions (20% of patients or more) were peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.

 Source:

FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for multiple myeloma. Press Release. The US Food and Drug Administration. Published online July 30, 2024. Accessed July 31, 2024. http://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-multiple