Posted by Michael Wonder on 30 Jun 2016
Darzalex (daratumumab) approved by Health Canada as the first human anti-CD38 monoclonal antibody for the treatment of multiple myeloma
30 June 2016 - Darzalex is a new therapy providing an important option for multiple myeloma patients who have received three or more prior lines of therapy.
Janssen announced today Health Canada has issued a notice of compliance with conditions approving Darzalex (daratumumab) for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are refractory to both a PI and an IMiD.
Health Canada approved this product on the condition that Janssen Inc. carries out confirmatory trials to verify the clinical benefit of Darzalex.
