Janssen Biotech announced that the Food and Drug Administration (FDA) has approved Darzalex (daratumumab) in combination with lenalidomide + dexamethasone or bortezomib + dexamethasone, for the treatment of multiple myeloma in patients who have received at least 1 prior therapy.

In clinical studies, Darzalex in combination with lenalidomide + dexamethasone, lowered the risk of disease progression or death by 63% vs. lenalidomide and dexamethasone alone, in patients with multiple myeloma who received a median of 1 prior therapy (hazard ratio [HR] 0.37, 95% CI: 0.27, 0.52; P<0.0001). In the Phase 3 open-label POLLUX study, estimated median progression-free survival (PFS) in the Darzalex arm has not been reached and was 18.4 months for patients who received lenalidomide and dexamethasone alone. The Darzalex arm had a significantly increased overall response rate (ORR) vs. lenalidomide and dexamethasone alone (91% vs. 75%; P<0.0001).  

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When combined with bortezomib + dexamethasone, Darzalex lowered the risk of disease progression or death by 61% vs. bortezomib and dexamethasone alone, in patients with multiple myeloma who received a median of 2 prior lines of therapy (HR 0.39, 95% CI: 0.28, 0.53; P<0.0001). In the Phase 3 open-label CASTOR study, the median PFS in the Darzalex arm has not been reached and was 7.2 months for patients who received bortezomib and dexamethasone alone. The Darzalex arm had a significantly increased ORR vs. bortezomib and dexamethasone alone (79% vs. 60%; P<0.0001). 

Darzalex, a CD38-directed monoclonal antibody, was initially approved by the FDA in November 2015 as monotherapy for patients with multiple myeloma who have received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or patients who are double refractory to a proteasome inhibitor and immunomodulatory agent. Lenalidomide is an immunomodulatory agent, and bortezomib is a proteasome inhibitor. 

Darzalex is supplied as a 100mg/5mL and 400mg/20mL strength solutions for IV infusion in single-dose vials. 

For more information call (800) 526-7736 or visit Darzalex.com.