Sanofi has announced that the European Commission has approved Sarclisa (isatuximab) for treating adult patients with relapsed and refractory multiple myeloma. The drug is indicated in patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
“The EC approval of Sarclisa represents an important additional therapeutic option and may set a new standard of care for myeloma patients in Europe who are in need of new effective treatments because their disease has returned or they have become refractory to their previous treatment,” said John Reed, Global Head of Research and Development at Sanofi.
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About the Phase 3 trial
The approval was based on the Phase 3 trial (ICARIA-MM). In this study, Sarclisa was administered along with pomalidomide and dexamethasone. The drug demonstrated statistically significant improvement in progression-free survival compared to pomalidomide and dexamethasone alone. The median PFS was 11.53 months in Sarclisa arm compared to 6.47 months in patients administered with pomalidomide and dexamethasone alone.
Sarclisa is a monoclonal antibody that binds to the CD38 receptor in multiple myeloma cells. CD38 cells are expressed highly and uniformly on multiple myeloma cells. The drug is intended to induce programmed cell death and immunomodulatory activity.
The drug has already been approved in the U.S, Switzerland, Canada, and Australia in combination with pomalidomide and dexamethasone.