[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]
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