Janssen announced that the Food and Drug Administration (FDA) has approved Darzalex (daratumumab) in combination with Velcade (bortezomib), melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
Darzalex, a CD38-directed antibody, is already approved to treat multiple myeloma as both monotherapy and combination therapy with various chemotherapy agents. VMP consists of Velcade, a proteasome inhibitor (PI); melphalan, an alkylating agent; and prednisone, a steroid.
The FDA approval was based on data from the Phase 3 randomized, open-label, multicenter ALYCONE study. The data showed combination therapy with Darzalex and VMP lowered the risk of disease progression or death by 50% vs VMP alone (hazard ratio [HR] 0.50, 95% CI: 0.38–0.65; P <.0001). Median progression-free survival (PFS) had not been reached for the Darzalex/VMP arm compared with 18.1 months for patients receiving VMP alone.
Moreover, overall response rates were significantly improved in the combination arm vs VMP alone (91% vs 74%). There was also notable improvements in complete response (18% vs 7%), complete response or better (43% vs 24%), and very good partial response or better (71% vs 50%). Study authors reported a greater than 3-fold increase in the minimal residual disease (MRD) negativity rate among patients who received Darzalex/VMP vs VMP alone (22% vs 6%).
Upper respiratory tract infection, infusion reactions, and peripheral edema were the most commonly reported adverse reactions (occurring ≥20%) with ≥5% greater frequency in the combination arm.
“This approval is significant as we now have the first antibody-based regimen for treating newly diagnosed multiple myeloma patients who are not eligible for a stem cell transplant,” said Andrzej Jakubowiak, MD, PhD, Director of the Multiple Myeloma Program at University of Chicago Medical Center, Chicago, Illinois and a Darzalex clinical study investigator.
For more information call (800) 526-7736 or visit Darzalex.com.