Sanofi-Aventis gets FDA OK for Sarclisa

Adult patients with multiple myeloma who have had previous therapies have a new treatment option. The Food and Drug Administration approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

Sarclisa, administered through intravenous infusion works by helping certain cells in the immune system attack multiple myeloma cancer cells.

"Targeting cells has led to the development of important oncology treatments. While there is no cure for multiple myeloma, Sarclisa is now another CD38-directed treatment option added to the list of FDAapproved treatments of patients with multiple myeloma who have progressive disease after previous therapies," said Richard Pazdur,  director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. "In the clinical trial, there was a 40% reduction in the risk of disease progression or death with this therapy."

Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow.