On 31 January 2025, Sanofi announced that China’s National Medical Products Administration (NMPA) has approved Sanofi’s Sarclisa® (isatuximab) in combination with 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.
Days earlier, on 28 January 2025, Pharmiweb reported that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has also approved Sarclisa® for the same combination therapy and indication.
This follows approval of the isatuximab combo by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) one week earlier. The combination therapy was also approved in the US in September 2024.
In November 2024, Sanofi succeeded in an appeal in the UK against the NICE’s June 2024 Final Draft Guidance recommending against Sarclisa® as a regimen alongside pomalidomide and dexamethasone for relapsed relapsed/refractory multiple myeloma (RRMM).