French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Sarclisa (isatuximab) in combination with pomalidomide plus dexamethasone. This approval is for the treatment of adult patients with multiple myeloma who have previously received at least first-line treatment, including lenalidomide and proteasome inhibitors. The NMPA’s approval makes Sarclisa the first blood cancer drug with approval based on real-world data (RWD) in Lecheng as key evidence.
Clinical and Real-World Study Results
The approval is supported by results from the global Phase II ICARIA-MM study and the China lsaFiRsT real-world study. The ICARIA-MM study demonstrated that isatuximab, in combination with pomalidomide and dexamethasone, significantly reduced the risk of disease progression or death by 40%, nearly doubled progression-free survival (PFS), and prolonged overall survival (OS), showing clinically significant survival benefits. The lsaFiRST real-world study in China further demonstrated that the combination yielded an 82.6% overall response rate (ORR) in recurrent or refractory multiple myeloma (RRMM) patients.
Significance of the Approval
This NMPA approval marks a significant milestone for Sanofi, as it expands the treatment options for patients with multiple myeloma in China. By leveraging both clinical trial data and real-world evidence, Sanofi has demonstrated the efficacy and safety of Sarclisa in treating this challenging disease, potentially improving patient outcomes and quality of life.-Fineline Info & Tech
