Japan approves Sanofi’s Sarclisa combo for MM treatment

Japan's Ministry of Health, Labour and Welfare has approved the subcutaneous formulation of Sarclisa (isatuximab) by Sanofi in combination with standard therapies for treating multiple myeloma. The approval is based on positive results from the IRAKLIA Phase III study, which demonstrated equivalent efficacy and pharmacokinetics compared to the intravenous formulation. The drug is approved in combination with pomalidomide and dexamethasone or with carfilzomib for treating relapsed or refractory multiple myeloma, as well as in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adults. The IRAKLIA study showed an objective response rate of 71.1% with the subcutaneous formulation combined with pomalidomide and dexamethasone compared to 70.5% with the intravenous formulation. The subcutaneous formulation demonstrated a safety profile consistent with the intravenous formulation, with a lower frequency of infusion-related reactions (1.5% versus 25%).