Posted by Michael Wonder on 22 Jan 2025
Sarclisa approved in the EU as the first anti-CD38 therapy in combination with standard of care VRd to treat transplant-ineligible newly diagnosed multiple myeloma
22 January 2025 - Approval is based on positive results from the IMROZ Phase 3 study, demonstrating Sarclisa in combination with standard of care treatment significantly improved progression-free survival, compared to the standard of care alone in transplant ineligible newly diagnosed multiple myeloma.
Following the adoption of a positive opinion by the EMA's CHMP, the EU has approved Sarclisa in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant, based on data from the IMROZ Phase 3 study.
