On 25 February 2025, Sanofi announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Sarclisa® (isatuximab), in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM).
The combination therapy was approved in a number of jurisdictions in January 2025, including China, the UK, and the European Union. It was also approved in the US in September 2024.
In November 2024, Sanofi succeeded in a UK appeal against the NICE’s June 2024 Final Draft Guidance recommending against Sarclisa® as a regimen alongside pomalidomide and dexamethasone for relapsed relapsed/refractory multiple myeloma (RRMM).