The U.S. Food and Drug Administration (FDA) recently approved Sanofi-Aventis’ Sarclisa (isatuximab-irfc) for the treatment of adult patients with multiple myeloma. Isatuximab-irfc was previously designated its orphan drug status by the FDA.
Isatuximab-irfc was approved based on its results from a clinical trial involving over 300 adult patients with relapsed and refractory multiple myeloma. These patients also previously received at least two other treatments for their condition.
Rixhard Pazdur, MD, the firector of the FDA’s Oncology Center of Excellence describes the approval and its impact on the condition: “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 FDA-approved treatments of patients with multiple myeloma who have progressive disease after previous therapies…In the clinical trial, there was a 40% reduction in the risk of disease progression or death with this therapy.”
Please read more about isatuximab-irfc’s approval here.