The European Commission (EC) has approved isatuximab (Sarclisa®) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction (i.e., initial) treatment of newly diagnosed myeloma patients (NDMM) who are eligible for autologous stem cell transplant. 

The decision follows an earlier positive recommendation of the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP – their scientific advisory committee) on 19 June 2025.

Marketing authorisation means that isatuximab is safe and effective for use in transplant eligible newly diagnosed myeloma patients. However, it should be noted that national patient access will further depend on the company’s marketing decisions and on national healthcare system assessments and approvals.

About isatuximab

Isatuximab is a monoclonal antibody. It binds to a protein called CD38 which is present on the surface of myeloma cells. By binding to this protein, isatuximab works to kill the myeloma cells. It also activates the immune system by marking the myeloma cells for destruction.

The European Commission approval was based on results from part one of the two-part, German-speaking Myeloma Multicenter Group (GMMG)-HD7 Phase III clinical trial. This trial showed that isatuximab, in combination with VRd, resulted in better outcomes for transplant eligible NDMM compared to VRd alone.

With this positive decision, isatuximab is now approved for four indications in Europe:

• in combination with pomalidomide and dexamethasone, for patients with relapsed/refractory myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.
• in combination with carfilzomib and dexamethasone, for myeloma patients who have received at least one prior therapy.
• in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of newly diagnosed myeloma patients who are ineligible for autologous stem cell transplant.
• in combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of newly diagnosed myeloma patients who are eligible for autologous stem cell transplant.

If you have any questions or require further information, please contact info@mpeurope.org