Press Release: Sarclisa approved in the EU as the first anti-CD38 therapy in combination with standard-of-care VRd to treat transplant-ineligible newly diagnosed multiple myeloma

Sarclisa Approval and Market Impact - Sarclisa has been approved in the EU as the first anti-CD38 therapy in combination with VRd for treating transplant-ineligible newly diagnosed multiple myeloma (NDMM) based on the IMROZ phase 3 study [1] - This approval marks the third indication for Sarclisa in the EU, including two for relapsed or refractory multiple myeloma (R/R MM) and one for NDMM [6] - Sarclisa is currently approved in over 50 countries, including the US and EU, across three indications [4] Clinical Development and Mechanisms - Sarclisa (isatuximab) is a CD38 monoclonal antibody that induces antitumor activity through mechanisms such as apoptosis and immunomodulatory activity [3] - The drug is part of a patient-centric clinical development program, with several phase 2 and phase 3 studies across six potential indications [5] - Sanofi is evaluating a subcutaneous administration method for Sarclisa in clinical studies [5] Regulatory Milestones and Global Expansion - The US FDA approved Sarclisa in combination with VRd for NDMM in September 2024, granting orphan drug exclusivity for this indication [2] - Regulatory submissions for Sarclisa in NDMM are under review in Japan and China [2] - The approval in the EU and US represents a significant step forward in addressing unmet needs in multiple myeloma treatment [2][6] Sanofi's Strategic Focus - Sanofi is committed to advancing oncology innovation, focusing on difficult-to-treat cancers such as multiple myeloma, acute myeloid leukemia, and certain lymphomas [6][7] - The company aims to become the leading global immunoscience company by leveraging its expertise in this field [6] - Sanofi's pipeline prioritization includes hematologic malignancies and solid tumors with critical unmet needs [6]