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Sanofi Receives China’s NMPA Approval for Sarclisa + SoC VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

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  • China’s NMPA has approved Sarclisa with SoC VRd (bortezomib, lenalidomide, & dexamethasone) to treat ASCT-ineligible NDMM pts based on data showing improved PFS in P-III (IMROZ) trial; ongoing regulatory review in Japan for HSCT- ineligible NDMM pts
  • This was preceded by NMPA approval of Sarclisa + pomalidomide & dexamethasone (Pd) for R/R MM pts who received ~1L therapy, incl. lenalidomide & a proteasome inhibitor on Jan 13, 2025
  • Sarclisa (mAb) binds to CD38 receptors on MM cells & utilizes multiple MoA incl. apoptosis and immunomodulation to trigger antitumor activity. Sanofi continues to develop it in several P-II and P-III studies along with SC formulation

Ref: Sanofi | Image: Sanofi

Related News:- The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

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