publication date: Dec. 2, 2016

Drugs & Targets Darzalex Approved for Multiple Myeloma; Iclusig Approved for CML

DARZALEX received FDA approval 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.

The drug is sponsored by Janssen Biotech Inc.

Clinical studies have shown that Darzalex, in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, reduced the risk of disease progression or death by 63 percent, compared to lenalidomide and dexamethasone alone, in patients with multiple myeloma who received a median of one prior therapy (Hazard Ratio [HR]=0.37; 95 percent CI [0.27, 0.52], p<0.0001), the company said.

In combination with bortezomib (a proteasome inhibitor [PI]) and dexamethasone, Darzalex reduced the risk of disease progression or death by 61 percent, compared to bortezomib and dexamethasone alone, in patients with multiple myeloma who received a median of two prior lines of therapy (HR=0.39; 95 percent CI [0.28, 0.53], p<0.0001).1 Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.

Darzalex is the first CD38-directed cytolytic antibody approved anywhere in the world. It was first approved by the FDA in November 2015 as a monotherapy treatment for patients with multiple myeloma who have received at least three prior lines of therapy, including … Continue reading Darzalex Approved for Multiple Myeloma; Iclusig Approved for CML

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