June 3, 2024. Sanofi issued a press release stating that its CD38 monoclonal antibody Sarclisa has been approved in the United States as the first anti-CD38 therapy.
Sarclisa is the first anti-CD38 drug to significantly improve progression-free survival in combination with VRd for the treatment of newly diagnosed transplant-eligible multiple myeloma.
Approval based on positive results from the IMROZ phase 3 study demonstrating Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved progression-free survival (PFS), compared to standard-of-care in newly diagnosed adult patients not eligible for autologous stem cell transplant (ASCT).
Third indication for Sarclisa, evaluated under FDA Priority Review, underscores Sanofi’s commitment to helping close a critical care gap in multiple myeloma (MM).
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