Headline: Sanofi's Sarclisa Subcutaneous Therapy Gains Japanese Approval for Multiple Myeloma

Sanofi (SNY) announced on June 19, 2026, that Japan's Ministry of Health, Labour and Welfare (MHLW) approved its Sarclisa (isatuximab) subcutaneous (SC) formulation. This approval targets adult patients with relapsed or refractory multiple myeloma (RRMM), in combination with pomalidomide and dexamethasone (Pd). The new formulation offers a more convenient administration option for patients. The MHLW's decision is based on results from the Phase 3 IMROZ study and the Phase 1b/2 IKEMA study. These trials demonstrated the SC formulation's non-inferior pharmacokinetics, safety, and efficacy compared to the existing intravenous (IV) formulation. Sarclisa, an anti-CD38 antibody, aims to provide a faster and more flexible treatment experience, potentially allowing administration in non-hospital settings.