On 22 January 2025, Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved Sarclisa® (isatuximab) 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).
This news follows the CHMP’s positive recommendation (November 2024) and US FDA approval (September 2024) for the same combination therapy and indication. In November 2024, Sanofi succeeded in an appeal in the UK against the NICE’s June 2024 Final Draft Guidance recommending against Sarclisa® as a regimen alongside pomalidomide and dexamethasone for relapsed relapsed/refractory multiple myeloma (RRMM).