Following a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on June 19, 2025, the European Commission has approved Sanofi’s Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant.
“This approval marks a significant milestone in our mission to broaden access to Sarclisa for people living with multiple myeloma,” said Olivier Nataf, Global Head of Oncology at Sanofi. “It demonstrates our continued commitment to advancing Sarclisa’s development, with the goal of delivering impact across all lines of therapy, regardless of transplant eligibility.”
The approval is based on findings from part one of the double-randomized, two-part phase 3 GMMG-HD7 study (NCT03617731) conducted by the German-speaking Myeloma Multicenter Group. The trial independently evaluated the efficacy of Sarclisa during both induction and maintenance therapy. In transplant-eligible NDMM patients, Sarclisa-VRd delivered a significantly higher rate of minimal residual disease (MRD) negativity after the 18-week induction period—meeting the primary endpoint—when compared to VRd alone.
This MRD advantage translated into a statistically significant and clinically meaningful improvement in progression-free survival (PFS), regardless of the maintenance regimen received. Notably, 53.1% of patients in the Sarclisa-VRd arm achieved sustained MRD negativity from post-induction through post-transplant, compared to 38% in the control arm, supporting the long-term PFS benefit.
These results further strengthen the evidence base for using Sarclisa in front-line treatment settings and highlight the potential of Sarclisa-VRd to enhance outcomes when used prior to transplant. Data from the maintenance phase (part two of the study) are expected in the near future.
With four approved indications globally—including two in the front-line setting—Sarclisa is increasingly recognized as a key therapeutic option in multiple myeloma. This latest EU approval reinforces Sanofi’s commitment to addressing critical unmet needs and improving outcomes throughout the multiple myeloma treatment continuum.