On 22 January 2025, the European Commission approved an isatuximab combination for the treatment of newly diagnosed myeloma patients who are not eligible for a stem cell transplant in the EU. This follows a positive recommendation from the Committee for Medicinal Product for Human Use (CHMP) in November 2024. The CHMP is the European Medicines Agency’s (EMA) committee playing a significant role in the assessment and authorisation of human medicines.

The combination is of isatuxumab, which is marketed by Sanofi as Sarclisa ®, with a standard-of-care treatment regimen bortezomib, lenalidomide and dexamethasone (VRd).

Isatuximab targets the CD38 protein, which is present on the surface of myeloma cells. By binding to this protein, isatuximab induces the death of myeloma cancer cells (also called apoptosis). Through the same mechanism, isatuximab activates the immune system by marking the myeloma cells for destruction.

The approval is a marketing authorisation extension, as isatuximab is already approved in Europe for use in later lines of therapy in two other combinations.

The approval followed the EMA CHMP positive opinion announced at the end of 2024, which was based on the results of the IMROZ phase III study. Watch this interview with Dr. Thierry Facon, professor of Haematology at Lille University Hospital in France explaining the results of the study at the 2024 European Hematology Association annual congress in Madrid, Spain. Access to more in-depth trial information can be found here. The trial continues to follow-up patients for data including overall survival rate, progression free survival rate and quality of life information.

This is the first treatment regimen for transplant-ineligible newly diagnosed myeloma patients that combines a standard-of-care treatment with a medicine that targets CD38. Pricing and reimbursement decisions will be taken at country level and therefore determine treatment availability.