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New Indication Alert: Sanofi’s Sarclisa® Combination Therapy for MM Approved in Japan

Feb 25, 2025

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In November 2024, Sanofi succeeded in a UK appeal against the NICE’s June 2024 Final Draft Guidance recommending against Sarclisa® as a regimen alongside pomalidomide and dexamethasone for relapsed relapsed/refractory multiple myeloma (RRMM).