The National Medical Products Administration (NMPA) in China has approved Sarclisa, in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT) based on data from the IMROZ phase 3 study.
Olivier Nataf, Global Head, Oncology, Sanofi, said: “When Sanofi entered China more than four decades ago, we did so with the intention of bringing potentially transformative therapies to Chinese patients. This approval, occurring just weeks after Sarclisa’s first in the country, represents tremendous progress towards advancing this mission. Now, patients with multiple myeloma and their providers have access to two new Sarclisa-based regimens that have the potential to improve outcomes across lines of therapy.”
This approval closely follows the decision from the NMPA earlier in January 2025, approving Sarclisa in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with relapsed or refractory MM (R/R MM) who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Beyond China, in the Asia-Pacific region, a regulatory submission for Sarclisa in NDMM patients not eligible for hematopoietic stem cell transplantation (HSCT) is currently under review in Japan.
Sarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for antibody-based therapeutics such as Sarclisa.
