French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Monday that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide and dexamethasone (VRd) for adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

A final regulatory decision is expected in the coming months.

The recommendation is based on data from the phase 3 GMMG-HD7 study, which demonstrated that Sarclisa-VRd significantly improved minimal residual disease negativity and progression-free survival compared to VRd alone. The trial results were presented at the 2024 American Society of Hematology Annual Meeting and published in the Journal of Clinical Oncology.

GMMG-HD7 is the first phase 3 study to show a deep and rapid response with an anti-CD38-based induction regimen in this patient population. The data also showed the highest post-induction and post-transplant MRD negativity rates of any CD38 monoclonal antibody using a VRd backbone.

If approved, this would be Sarclisa's fourth indication in the European Union and its second globally in the front-line multiple myeloma setting.

Sarclisa is currently approved in more than 50 countries, including the United States, the European Union, Japan and China, across multiple treatment lines.