French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Monday that China's National Medical Products Administration (NMPA) has approved Sarclisa, an anti-CD38 medicine, in combination with the standard treatment pomalidomide and dexamethasone (Pd), for the treatment of adult patients with multiple myeloma (MM) who have received prior therapies.

This approval is based on data from the ICARIA-MM phase 3 study and the China-based IsaFiRsT real-world study. ICARIA-MM demonstrated a significant reduction in the risk of disease progression or death and improved overall survival with Sarclisa-Pd compared to Pd alone. IsaFiRsT showed an overall response rate of 82.6% in relapsed or refractory MM patients.

Sarclisa was one of the first three treatments authorised for real-world studies under the Lecheng Pilot programme in China and is the first blood cancer treatment approved based on real-world evidence in addition to clinical data.

Sarclisa-Pd is currently recommended by the Chinese Society of Clinical Oncology (CSCO) and Chinese Anti-Cancer Association (CACA) treatment guidelines for this patient population. Sanofi is also pursuing regulatory approval for Sarclisa in combination with bortezomib, lenalidomide and dexamethasone (VRd) for newly diagnosed multiple myeloma (NDMM) in China.