Sarclisa subcutaneous form gains EU approval, expanding global reach
EU approves Sarclisa subcutaneous form; approvals pending in US, Japan, and China.
Event / Science
Sarclisa Subcutaneous EU Approval
Sanofi receives European Commission approval for Sarclisa subcutaneous formulation via portable injector for multiple myeloma treatment, marking the first such cancer treatment delivery method in the EU. Regulatory reviews are ongoing in the United States, Japan, and China with US FDA decision expected July 23. The treatment has been approved in approximately 60 countries since its 2020 launch with 70,000 patients prescribed globally.
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2026-08-16 to 2026-11-13 · UTC publication dates
Coverage begins 8 Jun, 08:37 UTC
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What happened
Sarclisa approved in approximately 60 countries since 2020 launch
Since its launch in 2020, Sarclisa, a monoclonal antibody treatment, has been approved in approximately 60 countries worldwide and prescribed to approximately 70,000 patients globally.
Sarclisa regulatory approval pending in United States, Japan, and China
Sanofi's Sarclisa subcutaneous formulation is under regulatory review by authorities in the United States, Japan, and China. The FDA delayed its decision by three months in April, with a decision expected on July 23.
European Commission approves Sanofi's Sarclisa subcutaneous injectable for multiple myeloma treatment
The European Commission approved Sanofi's Sarclisa (isatuximab) in subcutaneous formulation administered via a portable injector for treating multiple myeloma. This is the first cancer treatment in the EU approved for administration via a portable injector with manual subcutaneous injection, allowing flexible administration at patient homes or in ambulatory settings.
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