[Federal Register: February 20, 2003 (Volume 68, Number 34)]
[Notices]
[Page 8300]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20fe03-69]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 March 12 and 13, 2003,
from 8 a.m. to 5 p.m.
Location: Holiday Inn, Versailles 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, or email:
cliffordj@cder.fda.gov, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), code 12542.
Please call the Information Line for up-to-date information on this
meeting.
Agenda: The committee will discuss new drug applications approved
under 21 CFR 314.500 (Subpart H, accelerated approval) in an open
session on March 12 and 13, 2003, to: (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. On March 12, 2003, the committee will discuss phase IV
commitments of: (1) new drug application (NDA) 50-718 DOXIL
(doxorubicin HCl, Johnson and Johnson Pharmaceutical Research and
Development, L.L.C.) for the treatment of Kaposi's Sarcoma in acquired
immune deficiency syndrome (AIDS) patients with disease that has
progressed on prior combination therapy or in patients who are
intolerant to such therapy; (2) NDA 50-718/S-006 DOXIL (Doxorubicin
HCl, Johnson and Johnson Pharmaceutical Research and Development,
L.L.C.) for the treatment of metastatic ovarian cancer in patients with
disease that is refractory to both paclitaxel and platinum-based
chemotherapy regimens; (3) biologics license application (BLA) 97-1325
ONTAK (deneluekin diftitox, Ligand Pharmaceuticals) for the treatment
of persistent or recurrent cutaneous T-cell lymphoma whose malignant
cells express the CD25 component of the IL-2 receptor; and (4) NDA 20-
221/S-002, ETHYOL 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. On March 13, 2003, the committee will discuss phase IV
commitments of: (1) NDA 21-174, MYLOTARG (gemtuzumab ozogamicin, Wyeth-
Ayerst Laboratories, Inc.) for the treatment of CD33 positive acute
myeloid leukemia in first relapse of patients who are 60 years of age
or older and who are not considered candidates for cytotoxic
chemotherapy; (2) NDA 21-041, DEPOCYT (cytarabine, SkyePharma, Inc.)
for the intrathecal treatment of lymphomatous meningitis; (3) NDA 21-
156 CELEBREX (celecoxib, Pharmacia Corp.) indicated in the reduction in
number of adenomatous colorectal polyps in familial adenomatous
polyposis patients; and (4) NDA 21-029, TEMODAR (temozolomide, Schering
Corp.) for the treatment of adult patients with refractory anaplastic
astrocytoma.
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 March 3, 2003.
Oral presentations from the public will be scheduled between
approximately 8:15 a.m. and 8:45 a.m. and 12:30 p.m. to 1 p.m. on both
days. Time allotted for each presentation may be limited. Additional
open public sessions may be conducted after the presentations for
interested persons who have submitted their request to speak by March
3, 2003, to address issues specific to the topic before the committee.
Those desiring to make formal oral presentations should notify the
contact person before March 3, 2003, 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: February 10, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-4000 Filed 2-19-03; 8:45 am]
BILLING CODE 4160-01-S