French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) said on Wednesday that the European Union has approved Sarclisa (isatuximab), in combination with bortezomib, lenalidomide and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT).

This approval was based on positive results from the IMROZ phase 3 study, which demonstrated that Sarclisa significantly improved progression-free survival compared to standard-of-care VRd alone.

Sarclisa is the first anti-CD38 therapy approved in combination with VRd for this patient population in the EU. This represents the third indication for Sarclisa in the bloc, following two earlier approvals for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM).

Sanofi, the developer of Sarclisa, believes this approval marks a significant step forward in the treatment of multiple myeloma. Sarclisa is currently approved in more than 50 countries worldwide, including the US and EU, across three indications.

Sanofi continues to advance the clinical development of Sarclisa through ongoing phase 2 and phase 3 studies, including the evaluation of a subcutaneous administration method.