[Federal Register: October 14, 2005 (Volume 70, Number 198)]
[Notices]
[Page 60094-60095]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc05-52]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 is
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 November 8, 2005, from 8
a.m. to 5 p.m.
Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave.,
Gaithersburg, 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. The
background material will become available no later than the day before
the meeting and will be posted 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
under the heading ``Oncologic Drugs
Advisory Committee (ODAC).'' (Click on the year 2005 and scroll down to
ODAC meetings.)
Agenda: The committee will discuss new drug applications approved
under 21 CFR 314.500 and 601.40 (subparts H and subpart E,
respectively, accelerated approval regulations) in an open session to
do the following: (1) Review the status of phase IV clinical studies;
(2) identify difficulties associated with completion of phase IV
commitments; and (3) provide advice to sponsors to assist in the
planning and execution of postmarketing commitments of newly approved
drugs. The committee will discuss phase IV commitments of: (1) new drug
application (NDA) 50-718, DOXIL (doxorubicin hydrochloride liposome
injection, Johnson and Johnson Pharmaceutical Research and Development,
L.L.C.) for the treatment of acquired immune deficiency syndrome (AIDS)
related Kaposi's sarcoma in patients with disease that has progressed
on prior combination therapy or in patients who are intolerant to such
therapy; (2) NDA 20-221/S-002, ETHYOL for injection (amifostine,
MedImmune Oncology, Inc.) for reducing the cumulative renal toxicity
associated with repeated administration of cisplatin in patients with
advanced nonsmall cell lung cancer; (3) biologics license application
(BLA) 103767/0, ONTAK (denileukin diftitox, Seragen Incorporated) for
the treatment of patients with persistent or recurrent cutaneous T-cell
lymphoma whose malignant cells express the CD25 component of the
interleukin-2 receptor; (4) NDA 21-041, DEPOCYT (cytarabine liposome
injection, SkyePharma Inc.) for the intrathecal treatment of
lymphomatous meningitis; and (5) NDA 21-156, CELEBREX (celecoxib
capsules, Pfizer, Inc.) for reducing the number of adenomatous
colorectal polyps in familial adenomatous polyposis, as an adjunct to
usual care (e.g., endoscopic surveillance, surgery); (6) NDA 21-174,
MYLOTARG (gemtuzumab ozogamicin for injection, Wyeth Pharmaceuticals,
Inc.) for the treatment of patients with CD33 positive acute myeloid
leukemia
[[Page 60095]]
in first relapse who are 60 years of age or older and who are not
considered candidates for other cytotoxic chemotherapy; and (7) BLA
103948/0, CAMPATH (alemtuzumab, ILEX Pharmaceuticals, L.P.) for the
treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients
who have been treated with alkylating agents and who have failed
fludarabine therapy.
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 November 1,
2005. Oral presentations from the public will be scheduled between
approximately 2 p.m. to 3 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before November 1, 2005, 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.
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 Johanna Clifford 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: October 6, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-20559 Filed 10-13-05; 8:45 am]
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