Sanofi’s Sarclisa Earns Second EC Clearance for Multiple Myeloma
The European Commission (EC) has approved Sanofi’s Sarclisa (isatuximab) when combined with carfilzomib and dexamethasone for treating adults with relapsed multiple myeloma following a previous line of therapy.
The approval was supported by positive phase 3 study results from 302 patients in 16 countries, where the combination therapy was found to reduce the risk of disease progression or death by 47 percent compared with treatment with just carfilzomib and dexamethasone.
Nearly 30 percent of patients treated with the Sarclisa regimen had “a profound response with undetectable levels of multiple myeloma,” said trial investigator Philippe Moreau.
The FDA approved the combination therapy last month for treating adults with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy.