Sanofi’s Sarclisa is now the first anti-CD38 treatment in combination with standard-of-care VRd approved a for patients with newly diagnosed multiple myeloma ineligible for transplant

Sanofi announces that the National Medical Products Administration in China has recently approved Sarclisa, in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone, 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
“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.”

Note that, tis approval closely follows the decision from the NMPA earlier in January 2025, approving Sarclisa in combination with pomalidomide and dexamethasone 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.

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Related Topics and Keywords

anti-CD38 treatment, multiple myeloma, Sanofi, Sarclisa®