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Event Title
UPDATED INFORMATION: June 28-29, 2016: Meeting of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee
June 28-29, 2016

UPDATED INFORMATION: June 28-29, 2016: Meeting of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee - 06/27/2016 - 06/28/2016


Date:
June 28-29, 2016
Time:
June 28, 2016

UPDATED INFORMATION
The Agenda and Public Participation Information portions have been changed for the June 28-29, 2016 meeting of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee. There are no other changes.

The Agenda portion is changed to read as follows:

On June 28, 2016, information will be presented for expert assessments related to exploring potential pediatric development plans for four products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) venetoclax, presentation by AbbVie, Inc. (2) tazemetostat, presentation by Epizyme, Inc., and (3) atezolizumab, presentation by Roche/Genentech.

On June 29, 2016, during the morning session, information will be presented for expert assessments related to exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) LOXO-101, presentation by Loxo Oncology, Inc., and (2) entrectinib, presentation by Ignyta, Inc.

During the afternoon session, information will be presented on the current unmet clinical need in the nearly uniformly fatal brain tumor, diffuse intrinsic pontine glioma (DIPG) which occurs predominantly in the pediatric age group. The diagnosis of DIPG is typically based on characteristic radiographic and clinical features in lieu of brain biopsy, and histological confirmation. Recent data has demonstrated that the biology and pathophysiology of these tumors differ. There are no approved drugs for this disease. Clinical investigators seek to exploit precision medicine approaches to DIPG and use potentially predictive information from the genomic signature of tumors at either diagnosis or relapse. This information can be used to select specific molecularly targeted drugs based on the genetic aberrations of an individual patient’s tumor. The Agency will seek the input of the subcommittee, including an assessment of benefit/risk given the potential for an adverse event associated with a surgical intervention in the brainstem.

The Public Participation Information portion has been changed to extend the deadlines for written submissions and requests to speak during the scheduled open public hearing session and reads as follows:

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

  • Written submissions may be made to the contact person on or before June 24, 2016
  • Oral presentations from the public will be scheduled between approximately 8:50 a.m. and 9:10 a.m., 11:00 a.m. and 11:20 a.m., 1:55 p.m. and 2:15 p.m., on June 28, 2016, and between approximately 8:50 a.m. to 9:10 a.m., 10:55 a.m. to 11:15 a.m., and 3:05 p.m. to 3:25 p.m. on June 29, 2016. Those individuals interested in making 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 June 21, 2016.

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 June 22, 2016.


ORIGINAL INFORMATION

CenterDateTimeLocation
CDERJune 28, 2016
June 29, 2016
8:00 a.m.to 3:15 p.m
8:00 a.m.to 4:30 p.m
FDA White Oak Campus
Building 31
The Great Room (Rm 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland

Agenda

On June 28, 2016, information will be presented for expert assessments related to exploring potential pediatric development plans for four products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) venetoclax, application sponsored by AbbVie, Inc. (2) tazemetostat, application sponsored by Epizyme, Inc., and (3) atezolizumab, application sponsored by Roche/Genentech.

On June 29, 2016, during the morning session, information will be presented for expert assessments related to exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) LOXO-101, application sponsored by Loxo Oncology, Inc., and (2) entrectinib, application sponsored by Ignyta, Inc.

During the afternoon session, information will be presented on the current unmet clinical need in the nearly uniformly fatal brain tumor, diffuse intrinsic pontine glioma (DIPG) which occurs predominantly in the pediatric age group. The diagnosis of DIPG is typically based on characteristic radiographic and clinical features in lieu of brain biopsy, and histological confirmation. Recent data has demonstrated that the biology and pathophysiology of these tumors differ. There are no approved drugs for this disease. Clinical investigators seek to exploit precision medicine approaches to DIPG and use potentially predictive information from the genomic signature of tumors at either diagnosis or relapse. This information can be used to select specific molecularly targeted drugs based on the genetic aberrations of an individual patient’s tumor. The Agency will seek the input of the subcommittee, including an assessment of benefit/risk given the potential for an adverse event associated with a surgical intervention in the brainstem.

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 is available at: 2016 Meeting Materials, Oncologic Drugs Advisory Committee

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

  • Written submissions may be made to the contact person on or before June 22, 2016.
  • Oral presentations from the public will be scheduled between approximately 8:50 a.m. and 9:10 a.m., 11:00 a.m. and 11:20 a.m., 1:55 p.m. and 2:15 p.m., on June 28, 2016, and between approximately 8:50 a.m. to 9:10 a.m., 10:55 a.m. to 11:15 a.m., and 3:05 p.m. to 3:25 p.m. on June 29, 2016. Those individuals interested in making 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 June 16, 2016..

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 June 17, 2016.

Webcast Information

CDER plans to provide a free of charge, live webcast of the June 28-29, 2016 Meeting of the Pediatric 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: 2016 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

Lauren D. Tesh, PharmD, BCPS
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
Email: 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 disabilities. If you require special accommodations due to a disability, please contact Lauren D. Tesh 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 FDA 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).

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 disabilities. If you require accommodations due to a disability, please contact Lauren Tesh at (301) 796-9001 at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

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).