Johnson & Johnson’s Darzalex Faspro approved by FDA in multiple myeloma

Johnson & Johnson announced that the FDA approved Darzalex Faspro in combination with bortezomib, lenalidomide and dexamethasone – D-VRd – for induction and consolidation in patients with newly diagnosed multiple myeloma, or NDMM, who are eligible for an autologous stem cell transplant. Patients will have the opportunity to receive this Darzalex Faspro-based quadruplet therapy at initial diagnosis. 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 during induction and consolidation in patients with NDMM eligible for ASCT. Findings from the study demonstrated a significant improvement in the primary endpoint of progression-free survival, with D-VRd reducing the risk of disease progression or death by 60% compared to VRd. Treatment with D-VRd induction and consolidation resulted in deeper responses at the end of consolidation compared to VRd. The overall safety profile of D-VRd was consistent with the known safety profiles for Darzalex Faspro and VRd.