The country’s Ministry of Health, Labour and Welfare approved Sanofi’s push-button CirCLIQ Injector for administering a subcutaneous formulation of Sarclisa (isatuximab-irfc), a monoclonal antibody for multiple myeloma used in combination with standard-of-care regimens.
According to Enable, the CirCLIQ approval also marks the first in Japan for an anticancer treatment delivered by an on-body injector. The therapy has collected similar firsts this year in the U.S. and Europe — passing the FDA’s muster in July, with the drug marketed as Sarclisa Escena, shortly after receiving a European Union approval in June.