ET 06:30

Sanofi (SNY) Secures Japanese Approval for Subcutaneous Sarclisa in Multiple Myeloma

IMP6.0
SNT+1.0
CONF100%
Regulatory

Japan's Ministry of Health, Labour and Welfare (MHLW) on June 21, 2026, approved Sanofi's (SNY) subcutaneous formulation of Sarclisa (isatuximab) for the treatment of relapsed or refractory multiple myeloma. This approval provides a more convenient administration option for patients, enhancing Sanofi's oncology portfolio in a key market. The approval is based on data from the Phase 3 IMROZ study, which supported the efficacy and safety profile of subcutaneous Sarclisa. The drug is indicated for adult patients who have received at least one prior therapy, in combination with pomalidomide and dexamethasone. This new formulation aims to strengthen Sanofi's competitive position against existing multiple myeloma treatments.

EditorLim