[Federal Register Volume 68, Number 34 (Thursday, February 20, 2003)]
[Notices]
[Page 8300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-4000]


-----------------------------------------------------------------------

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: 
[email protected], 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