BRIEF—Sarclisa obtains first approval in China

13 January 2025

China’s National Medical Products Administration (NMPA) has approved French Pharma major Sanofi’s Sarclisa (isatuximab), an anti-CD38 medicine, in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.

This approval is based on results from the pivotal ICARIA-MM Phase III study, using the China-based IsaFiRsT real-world study as bridging data. The ICARIA-MM study demonstrated Sarclisa in combination with Pd significantly reduced the risk of disease progression or death by 40% (HR 0.596, 95% CI 0.44-0.81, p=0.001), and resulted in a clinically meaningful, 6.9-month improvement in overall survival (OS) (HR=0.78; log-rank 1-sided P=0.0319), compared to Pd alone.

Olivier Nataf, global head oncology, at Sanofi, commented: “This approval marks an important milestone for Sanofi in China. The results of the ICARIA-MM Phase III study, coupled with the real-world IsaFiRsT study, highlight the benefit of Sarclisa for patients living with multiple myeloma and the importance of innovative regulatory pathways for timely access to different treatments.”

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