FDA approves Darzalex + Velcade + melphalan + prednisone combination to treat newly diagnosed multiple myeloma.- Janssen Pharma.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Darzalex (daratumumab) in combination with Velcade (bortezomib), a proteasome inhibitor (PI); melphalan, an alkylating agent; and prednisone - VMP - for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). Darzalex is the first monoclonal antibody approved for newly diagnosed patients with this disease.

Clinical trial results showed Darzalex in combination with VMP reduced the risk of disease progression or death by 50 percent compared to treatment with VMP alone. The FDA approval of Darzalex in combination with VMP is supported by data from the randomized, open-label, multicenter Phase III ALCYONE (MMY3007) study, recently published in the New England Journal of Medicine. The combination of Darzalex with VMP reduced the risk of disease progression or death by 50 percent, compared to treatment with VMP alone (Hazard Ratio [HR] = 0.50; 95 percent CI [0.38-0.65], p<0.0001). The median progression-free survival (PFS) for Darazalex-VMP had not yet been reached, compared to a median PFS of 18.1 months for patients who received VMP alone.

Treatment with Darazalex in combination with VMP significantly improved overall response rates (91 vs. 74 percent) compared to VMP alone. Additionally, measures of stringent complete response (18 vs. 7 percent), complete response or better (43 vs. 24 percent) and very good partial response or better (71 vs. 50 percent) all showed marked improvement. Patients receiving Darzalex in combination with VMP achieved a more than three-fold increase in the minimal residual disease (MRD) negativity rate (22 vs. 6 percent) compared to those who received VMP alone.