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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.
The interim analysis results of the phase III IKEMA trial | Isatuximab + Kd for the treatment of relapsed and refractory multiple myeloma
Philippe Moreau, Steering Committee member of the MM Hub, and colleagues reported the results of Isa + Kd in...
Efficacy of Daratumumab outside the clinical trial setting
The efficacy of daratumumab combination regimens was studied in a more realistic treatment cohort.
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