The US Food and Drug Administration (FDA) has approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma (MM) who are eligible for autologous stem cell transplant.
The approval was based on data from the phase 3 PERSEUS study, which demonstrated a significant improvement in progression-free survival (PFS) with D-VRd compared with the VRd regimen. The D-VRd combination reduced the risk of disease progression or death by 60% (Hazard ratio: 0.40; P<0.0001).
The study also reported deeper responses at the end of consolidation with D-VRd, including higher minimal residual disease (MRD) negativity rates. The most common adverse reactions included peripheral neuropathy, fatigue, and upper respiratory infections.
“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,” Amrita Krishnan, MD, from the City of Hope, said in a statement provided by Johnson & Johnson, the manufacturer of the therapy. “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.”
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