Sanofi's Sarclisa SC Approved in Japan for Multiple Myeloma

Sanofi has announced that the Ministry of Health in Japan has approved Sarclisa's subcutaneous (SC) formulation for multiple myeloma (MM) patients. This decision is based on multiple studies, including the pivotal IRAKLIA phase 3 study, which demonstrated non-inferior efficacy compared to intravenous administration.

Sarclisa SC will be available in combination therapies, such as with pomalidomide and dexamethasone, for relapsed or refractory mm, and with bortezomib, lenalidomide, and dexamethasone for newly diagnosed cases. The approval is significant for Japan, where MM diagnoses are increasing.

A regulatory submission for the CirCLIQ on-body injector, allowing an innovative delivery method for Sarclisa, is also under review in Japan. If approved, it would be the first anticancer treatment to employ this method in the country.