[Federal Register: November 22, 2002 (Volume 67, Number 226)]


[Page 70445-70446]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]




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 December 17, 2002, from 

12:30 p.m. to 6 p.m. and December 18, 2002, from 8 a.m. to 3:30 p.m.

    Location: Holiday Inn, Versailles Ballrooms, 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, FAX 301-827-6776, e-

mail: SomersK@cder.fda.gov, 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 


    Agenda: On December 17, 2002, the committee will discuss biologics 

licensing application BL STN 125011/0, BEXXAR, Tositumomab (Anti-B1) 

and Iodine-131-Tositumomab, Corixa Corp., indicated for the treatment 

of patients with relapsed or refractory low-grade, follicular or 

transformed low-grade, B-cell non-Hodgkin's lymphoma (NHL) including 

patients with rituximab

[[Page 70446]]

refractory follicular NHL. On December 18, 2002, the committee will 

discuss new drug application (NDA) 20-498, S012, CASODEX (150 

milligrams bicalutamide), AstraZeneca Pharmaceuticals LP, indicated as: 

(1) Adjuvant therapy to radical prostatectomy and radiotherapy of 

curative intent in patients with locally advanced nonmetastatic 

prostate cancer who have a high risk for disease recurrence, or (2) 

immediate treatment of localized nonmetastatic prostate cancer in 

patients for whom therapy of curative intent is not indicated.

    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 December 10, 

2002. Oral presentations from the public will be scheduled between 

approximately 1:15 p.m. and 1:45 p.m. on December 17, 2002, and between 

approximately 8:15 a.m. and 8:45 a.m. on December 18, 2002. Time 

allotted for each presentation may be limited. Those desiring to make 

formal oral presentations should notify the contact person before 

December 10, 2002, 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 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 

December 10, 2002, to address issues specific to the topic before the 


    Background materials for this meeting will be posted at the 

Oncologic Drugs Advisory Committee Dockets Web site at http://

www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2002 and 

scroll down to the Oncologic Drugs Advisory Committee meetings.) The 

background materials for BEXXAR will be posted on December 16, 2002, 

and the background materials for CASODEX will be posted on December 17, 

2002. The slides and transcripts from the meeting will be posted at 

this same web address about 3 weeks after the meeting.

    Persons attending FDA's advisory committee meetings are advised 

that the agency is not responsible for providing access to electrical 


    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 Karen M. Templeton-

Somers 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: November 15, 2002.

Linda Arey Skladany,

Senior Associate Commissioner for External Relations.

[FR Doc. 02-29689 Filed 11-21-02; 8:45 am]