The International Myeloma Foundation is very pleased that Sarclisa (isatuximab-irfc), a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells, has just been approved by the FDA.
This approval means patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor have a new option.
Approval was based upon the ICARIA-MM study in which patients received a combination of Sarclisa plus pomalidomide and dexamethasone (pom/dex) versus pom/dex alone. The risk of progression was reduced by 40%, a very meaningful improvement in outcome. It is excellent to have one more potent agent available for relapsing patients.
--comments by Dr. Brian G.M. Durie, IMF Chairman of the Board