|CDER||September 14, 2011||8:00 a.m. to 5:00 p.m.||FDA White Oak Campus|
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
During the morning session, the committee will discuss new drug application (NDA) 021825, with the proposed trade name FERRIPROX (deferiprone) film-coated 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 non-metastatic 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 non-metastatic 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.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
- Written submissions may be made to the contact person on or before August 30, 2011.
- Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11:00 a.m. and 3 p.m. to 3:30 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 22, 2011.
CDER plans to provide a free of charge, live webcast of the September 14, 2011, meeting of the Oncologic Drugs Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2011 Meeting Materials, Oncologic Drugs Advisory Committee. CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
- Caleb Briggs, Pharm.D.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area) - follow the prompts to the desired center or product area
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Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caleb Briggs at (301) 796-9001 at least 7 days in advance of the meeting.
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Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).