Janssen Receives Health Canada Approval of Darzalex by Priority Review for Patients with Multiple My

Janssen Inc. has announced Health Canada has approved Darzalex (daratumumab), 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. Due to the unmet medical need for multiple myeloma patients, DARZALEX was granted a Priority Review by Health Canada for this submission.

In June 2016, Health Canada issued a Notice of Compliance with Conditions approving Darzalex for those 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 a PI and an IMiD. With this new approval, patients can now use Darzalex treatment earlier in their disease.

Data from two Phase three studies supported this new approval.  They include the open-label, randomized clinical studies Pollux (MMY3003) and Castor (MMY3004).