Sanofi's Sarclisa (isatuximab) has gained approval from Japan’s Ministry of Health, Labour and Welfare for use in conjunction with bortezomib, lenalidomide and dexamethasone (VRd) to treat adults with newly diagnosed multiple myeloma (NDMM).

The outcomes from the Phase III IMROZ study support the decision.

Sanofi Oncology global head Olivier Nataf stated: “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.”

Since its initial launch in Japan in August 2020, the therapy has been approved for four treatment regimens for relapsed or refractory MM, including as a single agent and in conjunction with other therapies.

Sarclisa, with the combination regimens, recently gained approval from China’s National Medical Products Administration, in particular for the Sarclisa-VRd combo for treating NDMM individuals who are ineligible for autologous stem cell transplants.

It also gained approval for use in conjunction with pomalidomide and dexamethasone for treating adults with relapsed or refractory MM who had undergone a minimum of one previous therapy line.

Sarclisa's mechanism of action involves binding to a certain epitope on the cluster of differentiation 38 receptor, which is expressed on MM cells.

The therapy has received approval in more than 50 nations and regions, including the EU, Japan, China and the US, for several indications.

In the EU, Japan and the US, Sarclisa plus Pd is approved for individuals with relapsed or refractory MM who have undergone two or more previous therapies, including lenalidomide and a proteasome inhibitor. This combination is also approved in China for subjects who have a minimum of one previous therapy.

Before this announcement, the US Food and Drug Administration (FDA) accepted a supplemental biologics licence application of Sanofi and Regeneron’s Dupixent, for priority review, with a decision anticipated by 20 June 2025.