Sanofi’s Sarclisa (isatuximab) has been approved by the European Commission (EC) to treat adults with newly diagnosed multiple myeloma (MM).
The drug has been specifically authorised for use alongside standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) to treat patients who are not eligible for autologous stem cell transplant.
MM is the second most common blood cancer after non-Hodgkin lymphoma, with approximately 46,000 cases of the disease expected to be diagnosed in Europe in 2025.
Despite available treatments, MM remains incurable and newly diagnosed patients have a five-year survival rate of about 52%.
Sanofi’s Sarclisa, which is already approved in the EU to treat certain cases of pre-treated MM, is designed to bind to the CD38 protein on MM cells and induce distinct anti-tumour activity.
The EC’s latest decision on the drug follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage IMROZ study.
The trial met its primary endpoint, with Sarclisa plus VRd followed by Sarclisa/Rd demonstrating a 40% reduction in the risk of disease progression or death compared to VRd followed by Rd.
Median progression-free survival (PFS) with the Sarclisa/VRd combination was not reached after a median follow up of 59.7 months versus 54.3 months with Vrd, and the estimated PFS at 60 months was 63.2% for patients treated with Sarclisa/VRd compared to 45.2% for those receiving VRd.
Benefits were also seen across the study’s secondary endpoints, with 74.7% of patients in the Sarclisa/VRd cohort achieving a complete response (CR) compared to 64.1% in the VRd group, and 55.5% of Sarclisa/VRd-treated patients reaching minimal residual disease negative CR compared to 40.9% of those receiving VRd.
Olivier Nataf, global head of oncology at Sanofi, said: “While there have been many important advancements in MM treatment over the past decade, there remains a significant unmet need in the front-line setting, particularly for transplant-ineligible patients.
“With [this] decision the 27 countries in the EU will have access to a potentially transformative new combination regimen, marking a significant step forward in our mission to make a meaningful difference in MM treatment.”