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

Shots: 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…

ByDipanshu DixitJanuary 31, 2025

NEWS

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

Shots: The EC has approved Sarclisa with SoC VRd (bortezomib, lenalidomide, & dexamethasone) to treat ASCT-ineligible NDMM patients, following the CHMP’s positive opinion. Regulatory findings are under review in Japan & China Approval was based on a P-III (IMROZ) study assessing Sarclisa + VRd vs VRd, which showed improved PFS of 40% (1EP) with findings reported…

ByRidhi RastogiJanuary 22, 2025

INSIGHTS+

Insights+: The US FDA New Drug Approvals in March and April 2020

The US FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products so far in 2019. However, there is a significant increase in multiple diseases while the new approvals are helping and advancing the changes to understand, diagnose, and treat the diseases Our team…

BySenior EditorMay 15, 2020

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

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

Insights+: The US FDA New Drug Approvals in March and April 2020

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