FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Health Canada Approves Janssen’s Darzalex in Multiple Myeloma

April 20, 2017
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Health Canada approved Janssen’s Darzalex, 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. Darzalex had been granted Priority Review.

In June 2016, Health Canada issued a Notice of Compliance with Conditions approving Darzalex for patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent, or who are refractory to both the inhibitors and not responsive to the drug.

Data from two Phase III studies supported this new approval: one trial showed significantly improved progression-free survival with the addition of Darzalex compared to lenalidomide and dexamethasone alone — the other, evaluating the addition of Darzalex to a combination of bortezomib and dexamethasone, demonstrated a 61 percent reduction in the risk of disease progression or death.

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