
[Federal Register Volume 77, Number 105 (Thursday, May 31, 2012)]
[Notices]
[Pages 32125-32126]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 24, 2012, from 8 
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 
20993-0002. Information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You,'' click on ``Public Meetings at the FDA White Oak 
Campus.'' Please note that visitors to the White Oak Campus must enter 
through Building 1.
    Contact Person: Caleb Briggs, 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: ODAC@fda.hhs.gov, or FDA Advisory Committee Information 
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), to find 
out further information regarding FDA advisory committee information. 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/
Advisory

[[Page 32126]]

Committees/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.
    Agenda: During the morning session, the committee will discuss 
supplemental new drug application (sNDA) 022059/014 with the trade name 
Tykerb (lapatinib) tablets, application submitted by SmithKline Beecham 
(Cork) Ltd, Ireland d/b/a GlaxoSmithKline. The proposed indication 
(use) for this product is in combination with trastuzumab for the 
treatment of patients with metastatic breast cancer whose tumors 
overexpress HER2 and who have received prior trastuzumab therapy(s).
    During the afternoon session, the committee will discuss the 
evaluation of radiographic review in randomized clinical trials using 
progression-free survival (PFS) as a primary endpoint in non-
hematologic malignancies. They will consider the merits of an 
independent audit of investigator progression assessment in a pre-
specified subgroup of patients instead of an independent review of all 
progression assessments. The expectation is that an independent audit 
would streamline the conduct of clinical trials, as well as avoid 
missing data when no additional protocol specified progression 
assessments are mandated. Hematologic malignancies are excluded from 
this discussion because other issues (e.g., blood counts, lymph node 
exams, and other biomarkers) influence the assessment of PFS.
    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 link.
    Procedure: 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 July 
10, 2012. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. 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 
29, 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 July 2, 2012.
    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 
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: May 24, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-13156 Filed 5-30-12; 8:45 am]
BILLING CODE 4160-01-P


