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.
Sebela Pharmaceuticals' tegoprazan Phase 3 TRIUMpH studies in GERD achieve positive topline results
BioArctic secures European substance patent for Parkinson's drug candidate exidavnemab
Pharming receives UK NICE recommendation for Joenja to treat APDS in patients aged 12 and older
Tagworks Pharmaceuticals' TGW101 IND application granted FDA clearance for Phase 1 clinical trial
1Cell.Ai launches OncoIncytes multi-modal cancer diagnostic panel
Viatris seeks Japanese approval for Effexor for generalised anxiety disorder
Kelun-Biotech's SKB518 granted IND clearance by US FDA
WuXi Biologics completes PPQ campaign at 15,000L production line in Hangzhou
SparX to present Phase 1 clinical update during AACR 2025
Sol-Gel Technologies sells US rights to EPSOLAY and TWYNEO to Mayne Pharma for USD16m
Clario partners with AWS on advancing clinical data analysis with generative AI
Mezzion Pharmaceuticals welcomes dedicated ICD-10 diagnosis codes for Fontan-associated conditions
TNF Pharmaceuticals showcases isomyosamine's clinical promise at BGS Spring Meeting 2025