The FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended accelerated approval of the iron chelator deferiprone (Ferriprox, ApoPharma) for patients with transfusional iron overload that is inadequately treated with deferoxamine (Desferal), the standard chelation therapy for patients with diseases such as thalassemia or sickle-cell disease, who must undergo multiple blood transfusions to survive.
Approximately 25% of patients with thalassemia do not respond adequately to standard iron chelation treatment. Clinical data show that among transfusion-dependent pa - tients who failed standard chelation therapy, 52% had successful treatment with deferiprone.
ODAC also recommended further assessment of clinical efficacy and safety, especially in patients with sickle- cell disease. (September 14, 2011)
