FDA Approves Daratumumab in Combination With VMP for Newly Diagnosed Multiple Myeloma
Posted: Thursday, May 10, 2018
On May 7, 2018, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with the proteasome inhibitor bortezomib (Velcade), the alkylating agent melphalan, and prednisone—VMP—for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). Daratumumab is the first monoclonal antibody approved for newly diagnosed patients with this disease. Clinical trial results showed daratumumab in combination with VMP reduced the risk of disease progression or death by 50% compared with treatment with VMP alone.
The FDA approval of daratumumab in combination with VMP is supported by data from the randomized, open-label, multicenter phase III ALCYONE (MMY3007) study, recently published by Mateos et al in The New England Journal of Medicine. Treatment with daratumumab in combination with VMP significantly improved overall response rates compared with VMP alone (91% vs .74%). Additionally, measures of stringent complete response (18% vs. 7%), complete response or better (43% vs. 24%), and very good partial response or better (71% vs. 50%) all showed improvement. Patients receiving daratumumab in combination with VMP achieved a more than threefold increase in the minimal residual disease (MRD) negativity rate (22% vs. 6%) compared with those who received VMP alone. Finally, the median progression-free survival for daratumumab plus VMP had not yet been reached, compared with 18.1 months for patients who received VMP alone.