Sanofi has announced that the European Union has approved Sarclisa for use in combination with a standard-of-care regimen, specifically bortezomib, lenalidomide, and dexamethasone. This approval applies to the treatment of adult patients newly diagnosed with multiple myeloma who are not eligible for autologous stem cell transplants. The decision was based on data from the phase 3 IMROZ study. With this expanded marketing authorization, Sarclisa becomes the first anti-CD38 therapy to be approved in combination with this regimen for this particular patient group within the EU.
Sarclisa has now been approved in over 50 countries, including both the United States and the European Union, for three clinical indications.
