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FDA approves isatuximab combined with carfilzomib and dexamethasone for the treatment of RRMM

Apr 1, 2021

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On March 31, 2021, it was announced that the U.S. Food and Drug Administration (FDA) approved the use of isatuximab (Isa) in combination with carfilzomib plus dexamethasone (Kd) for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy. This approval was based on results of the phase III IKEMA trial (NCT03275285), which were previously published on the Multiple Myeloma Hub and showed a 45% reduction in the risk of disease progression or death with Isa-Kd compared with Kd alone (HR, 0.548; 95% CI, 0.366–0.822; p = 0.0032).1

This Isa-Kd combination has also recently received a positive opinion by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for adult patients with MM previously treated with ≥1 line of therapy.

  1. Sanofi. FDA approves Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma. Published Mar 31, 2021. Accessed Apr 1, 2021.


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