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DARZALEX FASPRO® Approved For Transplant-Eligible Myeloma Patients

Johnson & Johnson's DARZALEX FASPRO® approved by FDA for newly diagnosed multiple myeloma treatment.

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  • Aug 01, 2024

  • Mrudula Kulkarni

DARZALEX FASPRO® Approved For Transplant-Eligible Myeloma Patients

Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to be used alongside bortezomib, lenalidomide, and dexamethasone (D-VRd) for both induction and consolidation therapy in newly diagnosed multiple myeloma (NDMM) patients eligible for autologous stem cell transplantation (ASCT).1 This new treatment offers patients a promising quadruplet therapy option right at the time of diagnosis, potentially enhancing their treatment outcomes.

The FDA's decision is backed by findings from the Phase 3 PERSEUS trial, which assessed DARZALEX FASPRO® within the D-VRd regimen against the standard VRd regimen for induction and consolidation in NDMM patients eligible for ASCT.1 After the consolidation phase, patients went on to receive an investigational maintenance treatment that included DARZALEX FASPRO® combined with lenalidomide or lenalidomide alone.

Amrita Y. Krishnan, M.D., Professor and Director of the Judy and Bernard Briskin Multiple Myeloma Center, City of Hope, said in a statement, “Multiple myeloma has a highly varied clinical course among patients and in each individual patient, and there is a continued need for innovation and therapies that employ different targets and combinations to provide patients with treatment options at diagnosis and throughout the course of their disease.

He further added, “The efficacy data supporting this new quadruplet regimen, combined with its established safety and tolerability profile, provide compelling evidence that adding D-VRd upon initial diagnosis as compared to VRd can deepen responses and prolong remissions in the context of autologous stem cell transplantation.”

Results from the PERSEUS study revealed a notable enhancement in the primary endpoint of progression-free survival (PFS). The D-VRd regimen lowered the risk of disease progression or mortality by 60% compared to the VRd regimen (HR [95% CI]: 0.40 [0.29, 0.57]; p < 0.0001).1 Furthermore, patients receiving D-VRd for induction and consolidation showed deeper responses at the end of the consolidation phase, achieving minimal residual disease (MRD) negativity rates of 57.5% versus 32.5% with VRd. Additionally, among patients who achieved a complete response (CR) or better, the MRD-negativity rates were 76.6% for D-VRd compared to 58.5% for VRd.

Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson, “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 safety profile of D-VRd aligned with the established safety profiles for both DARZALEX FASPRO® and VRd.1 Among multiple myeloma patients treated with D-VRd, the most frequently reported adverse reactions (occurring in 20% or more of patients) included peripheral neuropathy, fatigue, edema, fever, upper respiratory infections, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.

 

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