- FDA Announcements
FDA Approved for NDMM Transp. Ineligible: Daratumumab + Bortezomib (Velcade), Melphalan, Prednisone
HORSHAM, PA, May 7, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (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 3 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).1 The median progression-free survival (PFS) for DARZALEX®-VMP had not yet been reached, compared to a median PFS of 18.1 months for patients who received VMP alone.
05/07/2018: FDA Approval: