[Federal Register: August 17, 2005 (Volume 70, Number 158)]
[Page 48428-48429]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 September 13, 2005, from 8 
a.m. to 5 p.m. and on September 14, 2005, from 8 a.m. to 5 p.m.
    Location: Holiday Inn, The Ballrooms, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Johanna M. Clifford, 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, 
301-827-7001, FAX: 301-827-6776, e-mail: cliffordj@cder.fda.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. When available, 
background materials for this meeting will be posted 1 business day 
before the meeting on FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
 (Click on the year 2005 and scroll down to 

Oncologic Drugs Advisory Committee.)
    Agenda: On September 13, 2005, the committee will discuss the 
following: (1) New drug application (NDA) 21-491, proposed trade name 
XINLAY (atrasentan hydrochloride) Capsules, Abbott Laboratories, 
proposed indication for the treatment of men with metastatic hormone-
refractory prostate cancer; and (2) NDA 21-743, S003, TARCEVA 
(erlotinib) Tablets, OSI Pharmaceuticals Inc., proposed indication for 
the first-line treatment, in combination with gemcitabine, of patients 
with locally advanced, unresectable or metastatic pancreatic cancer. On 
September 14, 2005, the committee will discuss the following: (1) NDA 
21-880, proposed trade name REVLIMID (lenalidomide), Celgene Corp., 
proposed indication for the treatment of patients with transfusion-
dependent anemia due to low-or intermediate-1-risk myelodysplastic 
syndromes associated with a deletion 5q cytogenetic abnormality with or 
without additional cytogenetic abnormalities; and (2) NDA 21-877, 
proposed trade name ARRANON (nelarabine) Injection, GlaxoSmithKline, 
proposed indication for the treatment of patients with T-cell acute 
lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease 
has not responded to, or has relapsed with, at least two chemotherapy 
    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 by September 2, 
2005. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. to 11 a.m., and 2:30 p.m. to 3 p.m. on both 
days. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before September 2, 2005, and

[[Page 48429]]

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.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 Johanna Clifford at 
301-827-7001, at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 10, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-16331 Filed 8-16-05; 8:45 am]