[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Notices]
[Pages 1181-1182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-32]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-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 February 8, 2011, 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 ``White Oak Conference Center Parking 
and Transportation Information for FDA Advisory Committee Meetings''. 
Please note that visitors to the White Oak Campus must enter through 
Building 1.
    Contact Person: Nicole Vesely, 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-
8532, email: [email protected], or FDA

[[Page 1182]]

Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), and follow the prompts to the desired center 
or product 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 appropriate advisory committee hot line/phone line to 
learn about possible modifications before coming to the meeting.
    Agenda: The committee will hear updates on new drug applications 
(NDAs) and biologics license applications (BLAs) approved under 21 CFR 
314.500 and 601.40 (subpart H and subpart E, respectively, accelerated 
approval regulations) prior to January 1, 2009. These updates will 
provide information related to the status of phase IV clinical studies 
and to difficulties associated with completion of phase IV commitments. 
Phase IV studies are postmarketing studies to confirm clinical benefit 
of a drug after it receives accelerated approval.
    Specifically, the committee will receive updates on the following 
products: (1) BLA 125084, trade name ERBITUX (cetuximab), application 
submitted by Imclone Systems Inc., used in combination with the 
anticancer agent irinotecan and indicated for the treatment of 
epidermal growth factor receptor (EGFR)-expressing colorectal cancer 
that has metastasized (spread beyond the colon or rectum) in patients 
for whom chemotherapy using irinotecan alone is ineffective or less 
effective; (2) supplemental BLA (sBLA) 125011/24, trade name BEXXAR 
(tositumomab and Iodine I 131 tositumomab), application submitted by 
SmithKline Beecham Corp. doing business as (d/b/a) GlaxoSmithKline, 
indicated for the treatment of patients with varieties of non-Hodgkin's 
lymphoma known as CD20 antigen-expressing relapsed or refractory, low 
grade, follicular, or transformed non-Hodgkin's lymphoma, who have not 
received the drug Rituximab; (3) NDA 21-673, tradename CLOLAR 
(clofarabine) for intravenous infusion, application submitted by 
Genzyme Corp., indicated for the treatment of pediatric patients 1 to 
21 years old with acute lymphoblastic leukemia (ALL) whose disease has 
not responded to or has relapsed following treatment with at least two 
prior chemotherapy regimens; (4) NDA 21-877, tradename ARRANON 
(nelarabine) Injection, application submitted by GlaxoSmithKline, 
indicated for the treatment of patients with types of leukemia or 
lymphoma known as T-cell acute lymphoblastic leukemia and T-cell 
lymphoblastic lymphoma whose disease has not responded to or has 
relapsed following treatment with at least two chemotherapy regimens; 
(5) BLA 125147, tradename VECTIBIX (panitumumab), application submitted 
by Amgen Inc., indicated for the treatment of EGFR-expressing, 
metastatic colorectal carcinoma with disease progression on or 
following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing 
chemotherapy regimens; and (6) sNDA 21-588/025, tradename GLEEVEC 
(imatinib mesylate) tablets, application submitted by Novartis 
Pharmaceuticals Corp., indicated for the adjuvant (additional) 
treatment of adult patients following complete gross resection 
(removal) of a form of cancer known as Kit (CD117) positive 
gastrointestinal stromal tumors (GIST).
    Based on the updates provided, the committee will have a general 
discussion centering on possible ways to improve the planning and 
conduct of trials to confirm clinical benefit (post marketing 
requirements). The overall goal will be the optimization of the 
accelerated approval process with a focus on decreasing the amount of 
time to confirm (or fail to confirm) clinical benefit while continuing 
to provide early availability of promising oncology products.
    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 
January 25, 2011. Oral presentations from the public will be scheduled 
between approximately 1:30 p.m. and 2:30 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 January 14, 2011. 
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 January 18, 2011.
    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: January 3, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-32 Filed 1-6-11; 8:45 am]
BILLING CODE 4160-01-P