Findings from first-ever quadruplet therapy study with subcutaneous DARZALEX FASPRO® showed 60 percent reduction in risk of disease progression or death
New regimen solidifies DARZALEX FASPRO® as a foundational frontline therapy in multiple myeloma with potential to significantly delay disease progression
HORSHAM, Pa., July 30, 2024 /PRNewswire/ — Johnson & Johnson (NYSE:JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT).1 Patients will have the opportunity to receive this DARZALEX FASPRO®-based quadruplet therapy at initial diagnosis, providing them with a new treatment that may significantly improve outcomes.
This approval is supported by data from the Phase 3 PERSEUS study evaluating DARZALEX FASPRO® in a regimen that included D-VRd induction and consolidation therapy compared to bortezomib, lenalidomide and dexamethasone (VRd) during induction and consolidation in patients with NDMM eligible for ASCT.1 Following consolidation, patients received an investigational treatment regimen for maintenance that included DARZALEX FASPRO® in combination with lenalidomide or lenalidomide alone.1
“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,” said Amrita Y. Krishnan, M.D., Professor and Director of the Judy and Bernard Briskin Multiple Myeloma Center, City of Hope.* “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.”
Findings from the PERSEUS study demonstrated a significant improvement in the primary endpoint of progression-free survival (PFS), with D-VRd reducing the risk of disease progression or death by 60 percent compared to VRd (HR [95% CI]: 0.40 [0.29, 0.57]; p-value