CHMP Positive for Sarclisai (isatuximab in combination with bortezomib, lenalidomide, and dexamethasone newly diagnosed multiple myeloma ineligible for autologous stem cell transplant

A final decision is expected in the coming months.

Dietmar Berger, M.D., Ph.D. Chief Medical Officer, Global Head of Development at Sanofi; “The positive CHMP opinion is an important step forward for people with transplant-ineligible newly diagnosed multiple myeloma for whom effective front-line therapy may improve long-term outcomes. If approved, this Sarclisa-based combination could establish a new standard-of-care treatment approach for patients in the EU, helping to address a critical care gap in multiple myeloma treatment, and reinforcing Sarclisa’s potential as the anti-CD38 therapy of choice.”

In September 2024, the (FDA approved Sarclisa in combination with VRd for the treatment of adult patients with NDMM who are not eligible for ASCT, representing the first global approval for Sarclisa in the first line setting. In addition, the FDA granted orphan drug exclusivity for Sarclisa in the approved indication.

The positive CHMP opinion is based on data from the IMROZ phase III study, which was presented at the American Society of Clinical Oncology 2024 annual meeting, European Hematology Association 2024 meeting, and published in The New England Journal of Medicine (previously cited) IMROZ is the first global phase III study of a CD38 monoclonal antibody in combination with standard-of-care VRd to significantly improve progression-free survival (PFS) versus VRd alone. The safety and tolerability of Sarclisa observed was consistent with the established safety profile of Sarclisa and VRd with no new safety signal.