Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee
Meeting on September 14, 2011, from 8 a.m. to 5 p.m.

Agenda: On September 14, 2011, during the morning session, the committee will discuss new drug application 021825, with the proposed trade name Ferriprox (deferiprone) filmcoated tablets, application submitted by ApoPharma, Inc., represented by Cato Research Ltd. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of patients with transfusional iron overload (excess iron in the body related to blood transfusions), when current chelation therapy is inadequate. (Chelation therapy in these patients binds iron in a form that allows it to be eliminated from the body).
During the afternoon session, the committee will consider the development of products for the treatment of patients with nonmetastatic castration resistant prostate cancer (CRPC) who have a rising serum level of prostate-specific antigen (PSA) despite being on androgen deprivation therapy (ADT). There are no products currently approved for this indication. No specific products will be presented or discussed; rather, the committee will be asked to consider possible trial designs and suitable clinical endpoints to establish efficacy that would support a labeled indication for treatment of nonmetastatic CRPC after PSA progression on ADT. Because ADT is an unproven therapy for this condition with serious long-term toxicity, the committee will be asked whether approval of a new therapy in conjunction with continued ADT would be appropriate for patients with non-metastatic CRPC.