Darzalex Approved for Use with Two Standard of Care Regimens in Multiple Myeloma

Darzalex was initially approved by the FDA in November 2015
Darzalex was initially approved by the FDA in November 2015

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.

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