The U.S. Food and Drug Administration (FDA)gave the greenlight to Sanofi’s Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for adults with multiple myeloma who have had two previous therapies including lenalidomide and a protease inhibitor. Sarclisa is an intravenous (IV) drug, a CD38-directed cytolytic antibody.
“Today’s FDA approval of Sarclisa provides a new treatment option for patients with difficult-to-treat multiple myeloma,” said Paul Hudson, Sanofi’s chief executive officer. “These are patients whose disease has returned or become resistant to their prior treatment. At Sanofi, we are focused on discovering and developing medicines that may change the practice of medicine, and Sarclisa offers a potential new standard of care in the United States. We continue to evaluate Sarclisa in a comprehensive clinical program in multiple myeloma, as well as in other blood cancers and solid tumors.”
This approval marks the first time in a decade Sanofi has had a wholly-owned cancer drug approved. In a recent interview, Sanofi’s head of development, Dietmar Berger, called it a “return to oncology” for the company, which in recent years has tended to lean on its development partner Regeneron Pharmaceuticals to drive its innovation. The last wholly owned oncology compound the company received approval for was Jevtana in 2010. And Berger said, “Sarclisa is just the first molecule.”