[Federal Register Volume 63, Number 137 (Friday, July 17, 1998)]
[Notices]
[Pages 38658-38659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19030]


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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 regulatory issues.
    Date and Time: The meeting will be held on September 1, 1998, 8:30 
a.m. to 5:30 p.m., and September 2 and 3, 1998, 8 a.m. to 5:30 p.m.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: 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, 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 September 1, 1998, the committee will discuss: (1) New 
drug application (NDA) 20-893 MetaretTM (suramin hexasodium 
for injection), Parke-Davis Pharmaceutical Research, indicated for the 
treatment of patients with hormone refractory prostate cancer; and (2) 
NDA 20-892 ValstarTM (valrubicin 40 milligrams/milliliter), 
Anthra Pharmaceuticals, Inc., indicated for intravesical use in the 
treatment of patients with biopsy-proven carcinoma in situ of the 
urinary bladder who are refractory to bacille Calmette-Guerin (BCG) 
immunotherapy and for whom cystectomy is contraindicated. On September 
2, 1998, the committee will discuss: (1) NDA supplement 17-970/S-040 
Nolvadex (tamoxifen citrate), Zeneca Pharmaceuticals, 
indicated for the prevention of breast cancer in women at high risk; 
and (2) biologics license application (BLA) 98-0369 
HerceptinTM (trastuzumab), Genentech, Inc., indicated for 
the treatment of patients with metastatic breast cancer who have tumors 
which overexpress HER2. On September 3, 1998, the committee will 
discuss: (1) NDA supplement 20-571/S-08 CamptosarTM 
(irinotecan hydrochloride injection), Pharmacia & Upjohn, indicated for 
the treatment of patients with metastatic carcinoma of the colon or 
rectum whose disease has recurred or progressed following a 5-FU-based 
therapy; and (2) NDA supplement 20-451/S-003 Photofrin 
(porfimer sodium) for injection, QLT PhotoTherapeutics, Inc., indicated 
for the reduction of obstruction and palliation of symptoms in patients 
with completely or partially obstructing endobronchial nonsmall cell 
lung cancer.
    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 August 14, 
1998. Oral presentations from the public will be scheduled between 
approximately 8:45 a.m. and 9:15 a.m., on September 1, 1998, and 
between approximately 8:15 a.m. and 8:45 a.m., on September 2 and 3, 
1998. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before August 14, 1998, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

[[Page 38659]]

    Dated: July 9, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-19030 Filed 7-16-98; 8:45 am]
BILLING CODE 4160-01-F