Press Release: Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma

Sarclisa Approval in China - Sarclisa, an anti-CD38 medicine, has been approved by the National Medical Products Administration (NMPA) in China for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) in combination with pomalidomide and dexamethasone (Pd) [1] - The approval is based on the pivotal ICARIA-MM phase 3 study and the China-based IsaFiRsT real-world study, which demonstrated a 40% reduction in the risk of disease progression or death and a 6.9-month improvement in overall survival (OS) compared to Pd alone [2] - The IsaFiRsT study showed an overall response rate (ORR) of 82.6% among R/R MM patients [2] Clinical Studies and Results - The ICARIA-MM study enrolled 307 patients across 96 centers in 24 countries, with patients having received a median of three prior lines of therapy [6] - Sarclisa was administered intravenously at 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with Pd [7] - The primary endpoint was progression-free survival (PFS), with key secondary endpoints including ORR and OS [7] - The IsaFiRsT study enrolled 24 patients at one site in China, with a primary endpoint of ORR and key secondary endpoints including PFS, OS, and duration of response (DOR) [9][10] Regulatory and Guideline Recommendations - Sarclisa-Pd is included as a "Category I Recommendation" and "Preferred Option" in the Chinese Society of Clinical Oncology (CSCO) and Chinese Anti-Cancer Association (CACA) guidelines for first-relapsed MM [4] - A regulatory submission for Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma (NDMM) is under review in China [4] Sanofi's Commitment and Global Presence - Sanofi, one of the first multinational companies to enter China in 1982, is committed to accelerating the introduction of innovative medicines and vaccines in China [5] - Sarclisa is currently approved in more than 50 countries, including the US and EU, across multiple indications [12] - Sanofi is advancing Sarclisa through a patient-centric clinical development program, including phase 2 and phase 3 studies across six potential indications [13] Sarclisa Mechanism and Market Position - Sarclisa is a CD38 monoclonal antibody that induces antitumor activity through mechanisms such as apoptosis and immunomodulatory activity [11] - CD38 is highly expressed on multiple myeloma cells, making it a target for antibody-based therapeutics like Sarclisa [11] - Sanofi aims to become the leading immunoscience company globally, focusing on difficult-to-treat cancers such as multiple myeloma, acute myeloid leukemia, and certain lymphomas [14]