Janssen's Subcutaneous Daratumumab Quadruplet Therapy Receives FDA Approval for Newly Diagnosed Multiple Myeloma Patients Eligible for ASCT

Jul 31, 2024 19:00 CST Updated 19:00

Johnson & Johnson

Medical Device R&D and Manufacturer

On July 30, Johnson & Johnson announced that the U.S. FDA approved DARZALEX FASPRO® (Daratumumab and Hyaluronidase-fihj) with bortezomib, lenalidomide, and dexamethasone (D-VRd) Combined use for newly diagnosed multiple myeloma (NDMM)Induction and Consolidation Therapy for Patients, these patients are suitable for receiving autologous stem cell transplantation (ASCT). Patients will have the opportunity to receive this DARZALEX FASPRO-based treatment at the time of initial diagnosis.®The quadruple therapy offers them a new treatment option that may significantly improve outcomes.

Screenshot from: Johnson & Johnson official website

DARZALEX FASPRO® was approved by the U.S. FDA in May 2020 for the treatment of nine multiple myeloma indications, four of which are for frontline treatment of newly diagnosed patients eligible or ineligible for transplant.It is the only approved subcutaneous CD38-targeted antibody for the treatment of patients with multiple myeloma.。

The approval of the new indication this time was supported by data from the Phase III PERSEUS study, which evaluated the efficacy of DARZALEX FASPRO® in a regimen including D-VRd induction and consolidation therapy, and its use in combination with bortezomib, lenalidomide, and dexamethasone during induction and consolidation in NDMM patients suitable for ASCT.VRd) were compared. After consolidation therapy, patients received an investigational maintenance treatment regimen, including DARZALEX FASPRO in combination with lenalidomide or lenalidomide alone.

PERSEUS study results show that the primary endpoint, progression-free survival (PFS) Significantly improved. Compared with VRd,D-VRd Reduced the Risk of Disease Progression or Death by 60%Compared with VRd, induction and consolidation therapy using D-VRd can produce a deeper response at the end of the consolidation period:Minimal Residual Disease (MRD) The negative rate was 57.5% vs. 32.5%, complete remission (CR) or better, the MRD-negative rate was 76.6% vs. 58.5%。

The overall safety of D-VRd is consistent with the known safety profiles of DARZALEX FASPRO® and VRd. The most common adverse reactions in multiple myeloma patients treated with D-VRd (≥20%) are peripheral neuropathy, fatigue, edema, fever, upper respiratory tract infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.

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