French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Friday that it has received European Commission approval for Sarclisa in combination with bortezomib, lenalidomide and dexamethasone (VRd) as induction treatment for adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

This decision follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use issued on 19 June 2025.

Approval was based on part one of the GMMG-HD7 phase 3 trial, which showed that Sarclisa-VRd significantly improved minimal residual disease (MRD) negativity compared to VRd alone.

The study demonstrated a rapid and deep response to Sarclisa-VRd during the 18-week induction period, achieving the trial's primary endpoint. Patients treated with Sarclisa-VRd experienced a higher rate of sustained MRD negativity post-transplant (53.1% vs. 38%) and a statistically significant improvement in progression-free survival.

Sarclisa is now approved across all lines of multiple myeloma therapy in the European Union, regardless of transplant eligibility.

This marks the first global approval of Sarclisa for transplant-eligible newly diagnosed multiple myeloma.

Sanofi now holds four global approvals for Sarclisa, including two in front-line settings.