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EC approves isatuximab combined with carfilzomib and dexamethasone for the treatment of relapsed MM

Apr 20, 2021

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On April 19, 2021, it was announced that the European Commission (EC) approved the use of isatuximab (Isa) in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed multiple myeloma (MM) who have had ≥1 prior therapy. This approval was based on the results of the phase III IKEMA trial (NCT03275285), which were previously reported on the Multiple Myeloma Hub. They showed a 47% reduction in the risk of disease progression or death with Isa-Kd compared with Kd alone (HR, 0.531; 99% CI, 0.318–0.889; p = 0.0007).1

This Isa-Kd combination recently received approval from the U.S. Food and Drug Administration (FDA) for a similar indication, given on March 31, 2021.

  1. Sanofi.European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma. Published Apr 19, 2021. Accessed Apr 19, 2021.


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