[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
