European Commission Approves Sanofi’s Sarclisa for Multiple Myeloma

The European Commission has approved Sanofi’s Sarclisa (isatuximab) with pomalidomide and dexamethasone (pom-dex) for treatment of adults with relapsed and refractory multiple myeloma who have received at least two prior therapies and have shown disease progression.

The approval was based on the results of a phase 3 study in which the combination demonstrated a statistically significant improvement of progression-free survival and overall response rate compared to pom-dex alone.

Sarclisa was already approved in the U.S., Canada, Australia and Switzerland with pom-dex for  treatment of adults with relapsed refractory multiple myeloma.