Meetings: Oncologic Drugs Advisory Committee,
[Federal Register: July 17, 1998 (Volume 63, Number 137)]
[Notices]
[Page 38658-38659]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jy98-76]
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 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 Metaret‹SUP›TM‹/SUP› (suramin hexasodium for injection), Parke-Davis Pharmaceutical Research, indicated for the treatment of patients with hormone refractory prostate cancer; and (2) NDA 20-892 Valstar‹SUP›TM‹/SUP› (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‹Register› (tamoxifen citrate), Zeneca Pharmaceuticals, indicated for the prevention of breast cancer in women at high risk; and (2) biologics license application (BLA) 98-0369 Herceptin‹SUP›TM‹/SUP› (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 Camptosar‹SUP›TM‹/SUP› (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‹Register› (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. 98-19030Filed7-16-98; 8:45 am]
BILLING CODE 4160-01-F
