December 4, 2012: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting Announcement

Agenda

The subcommittee will receive a presentation on pediatric provisions mandated by the Food and Drug Administration Safety and Innovation Act. This will be an awareness presentation and there will not be a formal Committee discussion or recommendation. In addition, information will be presented regarding pediatric development plans for four products that are in development for an adult oncology indication. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The four products under consideration are: (1) Trametinib, application submitted by GlaxoSmithKline, LLC; (2) TH-302, application submitted by Threshold Pharmaceuticals, Inc.; (3) volasertib (BI 6727), application submitted by Boehringer Ingelheim Pharmaceuticals, Inc.; and (4) blinatumomab (MT 103), application submitted by Amgen Inc.

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 November 19, 2012.
• Oral presentations from the public will be scheduled between approximately 9:15 a.m. to 9:30 a.m., 11:15 a.m. to 11:30 a.m., 2:05 p.m. to 2:20 p.m., and 4:10 p.m. to 4:25 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 November 8, 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 November 9, 2012.

Webcast Information

CDER plans to provide a free of charge, live webcast of the December 4, 2012 meeting of the Pediatric Oncology Subcommittee 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

• Minh Doan, 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 Minh Doan at (301) 796-9001 at least 7 days in advance of the meeting.

Information regarding special accommodations due to a disability, visitor parking and transportation may 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).