
[Federal Register: November 17, 2009 (Volume 74, Number 220)]
[Notices]               
[Page 59195]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17no09-74]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
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 December 16, 2009, from 
8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD. The hotel phone number is 301-977-
8900.
    Contact Person: Nicole Vesely, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
(for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 
20857, 301-827-6793, FAX: 301-827-6776, e-mail: 
nicole.vesely@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 
3014512542. 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 appropriate advisory committee hot line/phone line to learn 
about possible modifications before coming to the meeting.
    Agenda: On December 16, 2009, during the morning session, the 
committee will discuss supplemental new drug application (sNDA) 021-
743/S-016, TARCEVA (erlotinib) tablets, by OSI Pharmaceuticals, Inc. 
The proposed indication (use) for this product is first-line 
maintenance, monotherapy (first-choice, single drug) treatment in 
patients with a form of lung cancer called non-small cell lung cancer 
(NSCLC) that is either locally advanced (has spread regionally within 
the lung and/or within chest lymph nodes) or metastatic (has spread 
beyond the lung), and who have not progressed (including those patients 
with stable disease) on first-line treatment with platinum-based 
chemotherapy (a regimen including a platinum drug (cisplatin or 
carboplatin) plus another chemotherapy drug).
    During the afternoon session, the committee will discuss 
supplemental new drug application (sNDA) 022-059/S-007, TYKERB 
(lapatinib) tablets, by SmithKline Beecham Ltd. doing business as 
GlaxoSmithKline. The proposed indication (use) for this product is in 
combination with an aromatase inhibitor for the treatment of hormone 
sensitive advanced or metastatic breast cancer. 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 
December 9, 2009. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. and 11 a.m., and 3:30 p.m. and 4 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 December 1, 2009. 
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 December 2, 2009.
    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 Nicole Vesely 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: November 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27490 Filed 11-16-09; 8:45 am]

BILLING CODE 4160-01-S
