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FDA Approves Daratumumab for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible

Approval in combination with VMP regimen marks fifth indication for daratumumab in multiple myeloma
18 May 2018
Haematologic malignancies;  Anticancer agents & Biologic therapy

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on 7 May 2018 that the US Food and Drug Administration (FDA) has approved daratumumab (DARZALEX®) in combination with bortezomib (VELCADE®), a proteasome inhibitor (PI); melphalan, an alkylating agent; and prednisone – VMP regimen - 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 multiple myeloma. 

The FDA approval of daratumumab in combination with VMP is supported by data from the randomised, open-label, multicentre phase III ALCYONE (MMY3007) study, recently published in the New England Journal of Medicine1. The combination of daratumumab with VMP reduced the risk of disease progression or death by 50%, compared to treatment with VMP alone (hazard ratio [HR] = 0.50; 95% CI [0.38-0.65], p<0.0001). The median progression-free survival (PFS) for daratumumab/VMP combination had not yet been reached, compared to a median PFS of 18.1 months for patients who received VMP alone. 

Treatment with daratumumab in combination with VMP significantly improved overall response rates (91 vs. 74%) compared to VMP alone. 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 marked improvement. Patients receiving daratumumab in combination with VMP achieved a more than three-fold increase in the minimal residual disease (MRD) negativity rate (22 vs. 6%) compared to those who received VMP alone. 

In the ALYCONE study, the most frequent adverse reactions (>20%) with at least 5% greater frequency in the daratumumab/VMP arm were upper respiratory tract infection (48 vs. 28%), infusion reactions (28 vs. 0%) and peripheral oedema (21 vs. 14%).  Serious adverse reactions with at least a 2% greater incidence in the daratumumab/VMP arm vs. VMP were pneumonia (11 vs. 4%), upper respiratory tract infection (5 vs.1%) and pulmonary oedema (2 vs. 0%).  The most common grade 3/4 treatment-emergent haematology laboratory abnormalities for daratumumab/VMP vs. VMP were lymphopenia (58 vs. 53%), neutropenia (44 vs. 43%) and thrombocytopenia (38 vs. 42%). The warnings and precautions for daratumumab include infusion reactions, interference with cross-matching and red blood cell antibody screening, neutropenia and thrombocytopenia. 

This latest FDA approval marks the fifth indication for daratumumab, the CD38-directed antibody and the first antibody approved for newly diagnosed patients with multiple myeloma who are transplant ineligible. Daratumumab was first approved by the FDA in November 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. Daratumumab received additional approvals in November 2016 in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. In June 2017, daratumumab received approval in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI.

The Janssen’s press release contains forward-looking statements.


1 Mateos MV, Dimopoulos MA, Cavo M, et al. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. NEJM 2018; 378(6):518-528. doi: 10.1056/NEJMoa1714678. 

Last update: 18 May 2018

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