[Federal Register Volume 66, Number 224 (Tuesday, November 20, 2001)]
[Notices]
[Page 58150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29137]


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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 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 December 5, 2001, from 
8:30 a.m. to 5:30 p.m., and on December 6, 2001, from 8 a.m. to 5:30 
p.m.
    Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver 
Spring, MD.
    Contact: Karen M. Templeton-Somers, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7001, e-mail: [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: On December 5, 2001, the committee will discuss: (1) The 
development of diagnostic immunohistochemistry (IHC) and fluorescence 
in situ hybridization (FISH) assays intended to identify patients who 
might benefit from treatment with a particular therapeutic product, 
with a focus on the characterization and interpretation of assay 
results; and (2) biologics licensing application 1037925008, a labeling 
supplement for HERCEPTIN (trastuzumab), Genentech, Inc., indicated for 
the treatment of patients with metastatic breast cancer who have tumors 
which overexpress HER-2. The proposed labeling supplement would include 
the use of FISH testing using the PATH VYSION HER-2 DNA Probe Kit, 
Vysis, Inc., as a diagnostic method to select patients for HERCEPTIN 
therapy. On December 6, 2001, the committee will discuss: (1) 
postmarketing safety issues associated with the use of CAMPTOSAR 
Injection (irinotecan hydrochloride injection), Pharmacia & Upjohn Co., 
combined with 5FU/leucovorin (``Saltz'' regimen) approved for the 
first-line treatment of patients with metastatic colorectal cancer. 
Potential labeling changes and issues regarding clinical trials to 
address the relevant safety and efficacy concerns will be discussed; 
and (2) supplemental new drug application (NDA) 20-637/S016, GLIADEL 
Wafer (carmustine), Guilford Pharmaceuticals, Inc., indicated for use 
as a treatment to significantly prolong survival and maintain overall 
function (as measured by preservation of Karnovsky Perfomance Status) 
and neurological function in patients with malignant glioma undergoing 
primary and/or recurrent surgical resection.
    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 27, 
2001. Oral presentations from the public will be scheduled between 
approximately 8:45 a.m. and 9:15 a.m., and 1:30 p.m. and 1:45 p.m. on 
December 5, 2001, and between approximately 8:15 a.m. and 8:45 a.m., 
and 1 p.m. and 1:15 p.m. on December 6, 2001. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before November 27, 
2001, 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. After the scientific 
presentations, a 30-minute open public session may be conducted for 
interested persons who have submitted their request to speak by 
November 27, 2001, to address issues specific to the topic before the 
committee.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 16, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-29137 Filed 11-16-01; 2:50 pm]
BILLING CODE 4160-01-S