Press Release: Sarclisa approved in Japan for patients with newly diagnosed multiple myeloma

Core Viewpoint - Sarclisa has been approved in Japan for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) in combination with bortezomib, lenalidomide, and dexamethasone (VRd), based on positive results from the IMROZ phase 3 study [1][6]. Company Developments - Sanofi has launched Sarclisa in Japan since August 2020, with approvals for multiple treatment regimens for relapsed or refractory multiple myeloma (R/R MM) [2][4]. - The company is committed to advancing innovative oncology treatments, particularly for difficult-to-treat hematologic malignancies, and has reshaped its pipeline to focus on these areas [8]. Product Information - Sarclisa (isatuximab) is a CD38 monoclonal antibody that induces antitumor activity through various mechanisms, including programmed tumor cell death and immunomodulatory effects [3]. - Currently, Sarclisa is approved in over 50 countries, including the US, EU, Japan, and China, for multiple indications [4]. Clinical Study Results - The IMROZ phase 3 study demonstrated that Sarclisa in combination with VRd significantly improved progression-free survival compared to VRd alone in transplant-ineligible NDMM patients [6]. - Sanofi is also evaluating a subcutaneous administration method for Sarclisa, with positive results reported from the IRAKLIA phase 3 study [5].