The European Commission (EC) has granted approval to Sanofi’s Sarclisa in combination with a regimen of bortezomib, lenalidomide and dexamethasone (VRd) to treat multiple myeloma in adults.
Sarclisa has received the EU approval for the induction treatment of transplant-eligible patients with newly diagnosed multiple myeloma (NDMM).
Go deeper with GlobalData
The EC’s approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in June 2025.
The decision is underpinned by the outcomes from part one of the German-speaking Myeloma Multicenter Group (GMMG)-HD7 Phase III trial, which evaluated Sarclisa’s impact independently in the induction and maintenance phases.
This randomised, pivotal, multicentre, open-label, two-part trial enrolled 662 subjects with transplant-eligible NDMM across 67 sites in Germany.
In the first part of the trial, Sarclisa was administered to subjects through an intravenous infusion at 10 mg/kg dose once a week for the initial four-week cycle, then every other week for the remainder of the induction period.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataSarclisa-VRd was found to have achieved a deep and quick response in transplant-eligible subjects.
The primary endpoint of the study was the rate of minimal residual disease negativity at the end of the induction period of 18 weeks.
Sanofi oncology global head Olivier Nataf stated: “We have been on a mission to accelerate Sarclisa’s clinical development programme with the hope to bring this important medicine to as many people as possible living with multiple myeloma.
“Today’s decision represents a prime example of those efforts, and most importantly, paves the way for Sarclisa to potentially become accessible to even more patients in the EU, regardless of transplant eligibility or line of therapy.”
Sarclisa, also known as isatuximab, received approval in more than 50 countries, including the US, the EU, China and Japan. With this latest approval, it has four global indications, two of which are in a front-line setting.
