Sarclisa approved in EU for treatment of multiple myeloma

Sanofi-Aventis announced that the European Commission has approved Sarclisa for the treatment of newly diagnosed multiple myeloma in adults who are not eligible for transplantation. This decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is based on positive results from the IMROZ Phase III study.

Sarclisa, in combination with VRd (bortezomib, lenalidomide and dexamethasone), thus becomes the first anti-CD38 approved for this specific use in the European Union. This approval offers a new option for patients for whom current alternatives are limited, addressing a significant medical need.

This advancement follows the approval of the US FDA in September 2024, where Sarclisa was also granted orphan drug status for this indication.