Sanofi’s Sarclisa Nabs FDA Approval for Previously-Treated Multiple Myeloma

The FDA approved Sanofi’s Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

The approval was based on the results of a clinical trial in which patients who received Sarclisa in combination with pom-dex demonstrated a statistically significant improvement in progression free survival.

Sarclisa received an orphan drug designation from the FDA and European Medicines Agency.