Johnson & Johnson (J&J) has won the US Food and Drug Administration (FDA) approval for the use of Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for multiple myeloma.
The approval is for the induction and consolidation treatment of patients with newly diagnosed multiple myeloma (NDMM) who qualify for an autologous stem cell transplant (ASCT).
Johnson & Johnson vice president and multiple myeloma disease area leader Jordan Schecter said: “This latest indication for Darzalex Faspro-based quadruplet therapy demonstrated a clinically significant reduction in disease progression or death during first-line treatment when patients are likely to experience their deepest responses.
“Today’s approval embodies our commitment to setting new standards of care for patients newly diagnosed with multiple myeloma who are transplant eligible.”
The FDA’s decision is based on data from the Phase 3 PERSEUS study, which assessed the efficacy of Darzalex Faspro in the D-VRd regimen compared to the standard bortezomib, lenalidomide, and dexamethasone (VRd) regimen.
The study involved D-VRd for both induction and consolidation phases, followed by an investigational maintenance treatment that included Darzalex Faspro either in combination with lenalidomide or as a standalone therapy.
The PERSEUS study demonstrated a 60% reduction in the risk of disease progression or death with D-VRd compared to VRd, with a hazard ratio of 0.40.
Additionally, the study showed that patients treated with D-VRd had a higher rate of minimal residual disease (MRD) negativity, at 57.5%, compared to 32.5% with VRd. Furthermore, patients with a complete response or better had MRD-negativity rates of 76.6% with D-VRd, compared to 58.5% with VRd.
The PERSEUS study is being conducted in collaboration with the European Myeloma Network and is still in progress. The randomised, open-label, Phase 3 trial is comparing the efficacy and safety of D-VRd versus VRd in NDMM patients eligible for ASCT.
The findings from the study, which is the first to evaluate a quadruplet therapy including subcutaneous Darzalex Faspro, support its role as a significant advancement in frontline treatment for multiple myeloma, potentially offering substantial delays in disease progression.
Darzalex Faspro, which received FDA approval in May 2020, is currently approved for nine indications in multiple myeloma, including four for frontline treatment of newly diagnosed patients.
It is the only subcutaneous CD38-directed antibody available for this condition and is co-formulated with recombinant human hyaluronidase PH20, using Halozyme’s ENHANZE drug delivery technology.
The development and commercialisation of daratumumab resulted from a worldwide agreement established in August 2012 between Janssen Biotech, a subsidiary of Johnson & Johnson, and the Danish biotechnology company Genmab.
Recently, Johnson & Johnson has recently filed a supplemental new drug application (sNDA) with the FDA for the approval of Spravato (esketamine) CIII nasal spray as a standalone treatment for adults with treatment-resistant depression. This application is underpinned by positive findings from the Phase 4 TRD4005 study, which assessed the drug’s efficacy, safety, and tolerability when used alone.
