Janssen’s Darzalex Combo for Multiple Myeloma Wins Approval in Canada

Health Canada has approved Johnson & Johnson subsidiary Janssen’s Darzalex (daratumumab) combination therapy for multiple myeloma patients eligible for stem cell transplantation.

The regulatory agency’s approval clears the monoclonal antibody, in combination with bortezomib, thalidomide and dexamethasone, for treating newly diagnosed multiple myeloma patients eligible for autologous stem cell transplants.

The clearance was based on results from a phase 3 trial that showed the addition of Darzalex before and after stem cell transplantation in first-line treatment significantly lessened the risk of progression of multiple myeloma and death.