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European Commission approves the second indication of isatuximab for relapsed multiple myeloma

April 19, 2021

The European Commission (EC) has approved isatuximab (Sarclisa®) in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy. This marks the second EC approval of isatuximab in combination with a standard of care regimen in less than 12 months.


“As there is no cure for multiple myeloma and patients often experience disease relapse, we must persist in our pursuit for additional treatment options. Nearly 30% of patients treated with the Sarclisa regimen had a profound response with undetectable levels of multiple myeloma,” said Philippe Moreau, M.D., Department of Hematology, University Hospital of Nantes, France. “This new therapeutic regimen has the potential to become a standard of care for patients with relapsed multiple myeloma, who now have another treatment option earlier in the progression of their disease.”


IKEMA study

This approval is based on data from the Phase 3 IKEMA study, a randomised, multi-centre, open-label clinical trial that enrolled 302 patients with relapsed myeloma. Isatuximab in combination with carfilzomib and dexamethasone reduced the risk of disease progression or death by 47% versus carfilzomib and dexamethasone.