CANCELLED: November 8, 2012: Oncologic Drugs Advisory Committee Meeting Announcement

UPDATED INFORMATION (as of 10/17/12):
CANCELLED: November 8, 2012: Oncologic Drugs Advisory Committee Meeting. This cancellation applies to both the morning session and afternoon session of the meeting. The issues for which the FDA was seeking the scientific input of the committee have been resolved.

UPDATED INFORMATION (as of 10/3/12):
CANCELLED: November 8, 2012: Oncologic Drugs Advisory Committee Meeting. This cancellation applies to both the morning session and afternoon session of the meeting.

Agenda

During the morning session, the committee will discuss new drug application (NDA) 204026, with the established name pomalidomide, application submitted by Celgene Corporation. The proposed indication (use) for this product is in combination with dexamethasone for patients with relapsed and refractory multiple myeloma who have received at least 2 prior regimens of established benefit, including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy.

During the afternoon session, the committee will discuss supplemental New Drug Application (sNDA) 021882/015, with the trade name Exjade (deferasirox) tablets for oral suspension, application submitted by Novartis Pharmaceutical Corporation. The proposed indication (use) for this product is for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes (beta-thalassemia intermedia, HbE beta-thalassemia, and alpha-thalassemia) aged 10 years and older.

Meeting Materials

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.

Background Material:

• 2012 Meeting Materials, Oncologic Drugs Advisory Committee

• Written submissions may be made to the contact person on or before October 25, 2012.
• Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11:00 a.m. and 3:30 p.m. to 4 p.m. on November 8, 2012. 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 October 17, 2012.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 18, 2012.

Webcast Information

CDER plans to provide a free of charge, live webcast of the November 8, 2012, 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: 2012 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

Contact Information

• Caleb Briggs, Pharm.D.
  Center for Drug Evaluation and Research
  Food and Drug Administration
  10903 New Hampshire Avenue
  WO31-2417
  Silver Spring, MD 20993-0002
  Phone: 301-796-9001
  Fax: 301-847-8533
  E-mail: ODAC@fda.hhs.gov

• FDA Advisory Committee Information Line
  1-800-741-8138
  (301-443-0572 in the Washington DC area)
  Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

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..

Information regarding ground transportation, airport information, lodging, driving directions and visitor parking, and security can be accessed at: Public Meetings at the White Oak Campus.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).