Sanofi’s Sarclisa Achieves First-in-Class Win, Poised to Surpass J&J in Multiple Myeloma Treatment

1. First-in-Class Win: Sanofi's Sarclisa (isatuximab) has achieved a first-in-class win by significantly improving progression-free survival in combination with VRd for newly diagnosed transplant-ineligible multiple myeloma patients.
2. IMROZ Study Results: The phase 3 IMROZ study demonstrated that Sarclisa in combination with VRd reduced the risk of recurrence or death by 40% compared to VRd followed by Rd in transplant-ineligible patients.
3. Regulatory Submissions: The FDA has accepted the supplemental Biologics License Application (sBLA) for Sarclisa's investigational use in combination with VRd, and a regulatory submission is under review in the European Union.
4. Potential Indication: If approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-of-care VRd for newly diagnosed patients not eligible for transplant, marking its third indication in multiple myeloma.
5. Presentations and Recognition: The IMROZ data will be presented at the European Hematology Association (EHA) Annual Congress and has been selected for the 2024 Best of ASCO program.