What is the role of isatuximab in the treatment of multiple myeloma (MM)?

Updated: May 11, 2021
  • Author: Dhaval Shah, MD; Chief Editor: Emmanuel C Besa, MD  more...
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The FDA approved the anti-CD38 monoclonal antibody isatuximab (Sarclisa) in March 2020 for relapsed or refractory MM in combination with pomalidomide and dexamethasone in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. Approval was based on the ICARIA-MM clinical trial (n = 307). The median PFS was 11.5 months in the isatuximab/pomalidomide/dexamethasone group compared with 6.5 months in the pomalidomide/dexamethasone group (P = 0.001). [7]  

In March 2021, the FDA approved isatuximab for use in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory MM who have received one to three prior lines of therapy. Approval was based on the phase III IKEMA trial (n=302), in which the addition of isatuximab to carfilzomab/dexamethasone resulted in a 45% reduction in the risk of disease progression or death. Median PFS was not reached in the isatuximab/carfilzomib/dexamethasone arm, compared with 20.27 months in the carfilzomib/dexamethasone arm (P = 0.0032). [96]  

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