Daratumumab and hyaluronidase-fihj received U.S. Food and Drug Administration (FDA) approval in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) to treat newly diagnosed multiple myeloma (MM) in patients who are eligible for autologous hematopoietic cell transplant (AHCT).
Data from the ongoing, randomized, open-label, phase III PERSEUS study supported the approval, with findings demonstrating significant improvement in progression-free survival. The trial found a 60% reduction in the risk of disease progression or death with D-VRd in comparison to VRd alone.
Common adverse reactions include insomnia, edema, upper respiratory infection, peripheral neuropathy, rash, constipation, musculoskeletal pain, pyrexia, diarrhea, and fatigue.
“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 [AHCT],” said Amrita Y. Krishnan, MD, professor and director of the Judy and Bernard Briskin Multiple Myeloma Center at City of Hope.
Source: PR Newswire, July 30, 2024.
