Sanofi (SNY.US) announced that the anti-CD38 monoclonal antibody has been approved in China for the treatment of multiple myeloma.

Today (January 9), Sanofi (SNY.US) has just announced that the market application for the monoclonal antibody Isatuximab injection has been approved by the National Medical Products Administration (NMPA) of China. Isatuximab (trade name: Sarclisa) is a novel monoclonal antibody targeting CD38. It has been approved for use in combination with pomalidomide and dexamethasone to treat adult patients with multiple myeloma who have received at least one prior therapy (including lenalidomide and proteasome inhibitors). This approval is based on the results of the global Phase 3 ICARIA-MM study and the Chinese IsaFiRsT real-world study. The ICARIA-MM study results showed that Isatuximab injection in combination with Pd therapy (Isa-Pd) significantly reduced the risk of disease progression or death by 40%, doubling the progression-free survival (PFS) and extending the overall survival (OS), demonstrating clinically meaningful survival benefits. The results of the IsaFiRsT real-world study conducted in China showed an overall response rate (ORR) of 82.6% in patients with relapsed or refractory multiple myeloma.