Sarclisa gains new approval in Japan

The Japanese Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Sarclisa (isatuximab), in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) based on data from the IMROZ Phase III study.

Currently approved in more than 50 countries, including in the USA, European Union, Japan, and China, across multiple indications, French pharma major Sanofi’s (Euronext: SAN) Sarclisa brought in fourth-quarter sales of $143 million last year. Sarclisa has faced challenges competing with Johnson & Johnson’s (NYSE: JNJ) Darzalex (daratumumab), which launched five years earlier and has captured significant market share.

Olivier Nataf, global head, oncology.at Sanofi, commented: “In recent years, new multiple myeloma cases have increased steadily in Japan and other Asian-Pacific nations, creating a need for new treatment approaches, particularly in the front-line setting. While Sarclisa-based combinations have been approved for relapsed or refractory patients in Japan, this approval represents the first indication for certain newly diagnosed patients. We are pleased to offer physicians an important new option for their patients earlier in the treatment journey, building upon our continued commitment to advancing innovative oncology treatments in difficult-to-treat hematologic malignancies around the world.”