Sanofi’s Sarclisa gains EU approval for multiple myeloma treatment
Ella Day | July 30, 2025 | News story | Medical Communications, Research and Development | European Commission, Oncology, Sanofi, Sarclisa, european union, multiple myeloma
Sanofi has received approval from the European Commission for the use of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) to treat adults with newly diagnosed multiple myeloma (NDMM) eligible for autologous stem cell transplant. This milestone makes Sarclisa one of the few treatments approved across all lines of therapy for multiple myeloma (MM) in the European Union, regardless of transplant eligibility.
The approval is based on findings from the first part of the GMMG-HD7 phase 3 study, which showed the Sarclisa-VRd delivered a statistically significant benefit in achieving minimal residual disease negativity at the end of the 18-week induction period – meeting the primary endpoint. Patients receiving Sarclisa-VRd also showed improved progression-free survival compared to those treated with VRd alone.
“This milestone represents our continued effort to make Sarclisa accessible to more people living with multiple myeloma,” said Olivier Nataf, global head of oncology at Sanofi. “We’re proud to offer a treatment that delivers deeper responses early in therapy and supports better long-term outcomes.”
Sanofi’s study enrolled 662 transplant-eligible patients across 67 sites in Germany and assessed Sarclisa both during induction and in maintenance therapy. While the second part of the study is ongoing, early results already demonstrate promise for Sarclisa’s role as a frontline MM treatment.
Sarclisa is now approved in over 50 countries and is emerging as a key component of Sanofi’s oncology portfolio.
Ella Day
30/7/25
Related Content
Sanofi and Regeneron’s Dupixent receives CHMP recommendation for chronic spontaneous urticaria
Sanofi and Regeneron have received a positive opinion from the European Medicines Agency’s (EMA) Committee …
European Commission approves HIV prevention injection
The European Commission (EC) has granted marketing authorisation for Gilead Science’s Yeytuo (lenacapavir), the first …
Sanofi’s treatment granted orphan designation for rare chronic inflammatory condition
The European Medicines Agency has granted orphan designation to Sanofi’s investigational Bruton’s tyrosine kinase (BTK) …
