[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Notices]
[Pages 39274-39275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14212]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Pediatric Oncology 
Subcommittee of the Oncologic Drugs Advisory Committee. The general 
function of the committee is to provide advice and recommendations to 
the Agency on FDA's regulatory issues. The meeting will be open to the 
public.

DATES: The meeting will be held on June 28, 2016, from 8 a.m. to 3:15 
p.m., and June 29, 2016, from 8 a.m. to 4:15 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area). 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 
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to 
the appropriate advisory committee meeting link, or call the advisory 
committee information line to learn about possible modifications before 
coming to the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: On June 28, 2016, information will be presented to gauge 
investigator interest in 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 to gauge investigator interest in 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.
    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 http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views,

[[Page 39275]]

orally or in writing, on issues pending before the subcommittee. 
Written submissions may be made to the contact person on or before June 
21, 2016. Oral presentations from the public will be scheduled between 
approximately 8:50 a.m. and 9:10 a.m., 11 a.m. and 11:20 a.m., 1:55 
p.m. and 2:15 p.m., and 3:50 p.m. and 4:05 p.m. on June 28, 2016, and 
between approximately 8:50 a.m. and 9:10 a.m., 10:55 a.m. and 11:15 
a.m., and 3 p.m. and 3:20 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.
    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 D. Tesh at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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).

    Dated: June 10, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-14212 Filed 6-15-16; 8:45 am]
BILLING CODE 4164-01-P