BRIEF—Health Canada approves of new use for Darzalex

US healthcare giant Johnson & Johnson subsidiary Janssen has received approval from Health Canada for Darzalex has approved (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).

This represents the first Canadian approval of a biologic for newly diagnosed patients who are eligible for a stem cell transplant and it is the fifth approval for Darzalex, which is licensed from Denmark-based biotech Genmab.

The approval is based on results from the Phase III CASSIOPEIA (MMY3006) study that demonstrated the addition of Darzalex to VTd before and after ASCT resulted in deeper responses, as indicated by the higher stringent complete response (sCR) rate, and improved progression-free survival (PFS) compared to VTd alone.