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FDA Oncologic Drug Advisory Committee to discuss the drug RSR13 used for metastatic brain tumors.


Posted on: 04/03/2004

FDA Oncologic Drug Advisory Committee to discuss drug used for brain tumors.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
April 1, 2004
FOR YOUR INFORMATION ON:

May 3 and 4, 2004
8:00 AM to 5:00 PM
The FDA will convene a meeting of the:
ONCOLOGIC DRUGS ADVISORY COMMITTEE
Location: Hilton Hotel
The Ballrooms
620 Perry Parkway
Gaithersburg, Maryland
301-977-8900

This two-day meeting is open to the public and will include public comment time. See times below.

TOPICS FOR DISCUSSION:
On May 3, 2004, the committee will discuss: (1) New drug application NDA 21-649, GENASENSE (oblimerse sodium) Genta, Inc., proposed indication for use in combination with DTIC DOME (dacarbazine) Bayer Parmaceuticals Corp., proposed for the treatment of patients with advanced malignant melanoma; and 2) NDA 21-661, RSR 13 Injection (efaproxiral sodium) Allos Therapeutics, Inc., proposed indication for use as an adjunct to whole brain radiation therapy in the treatment of brain metastases from primary breast cancer.

On May 4, 2004, the committee will discuss: (1) Safety concerns associated with ARANESP (darbepoetin alfa) Amgen, Inc., and PROCRIT (epoetin alfa) Ortho Biotech, L.P., both of which are indicated for the treatment of anemia associated with cancer chemotherapy; and (2) colorectal cancer endpoints as a followup to the November 2003 FDA Workshop.

For meeting updates call:

1-800-741-8138, code 12542
HOW DO I MAKE A FORMAL ORAL PRESENTATION?


Contact Johanna Clifford with the Center for Drug Evaluation and Research no later than April 26, 2004.
Johanna M. Clifford
Phone: 301-827-7001
Fax: 301-827-6776
E-Mail: cliffordj@cder.fda.gov

Time allotted will be limited and will depend upon the number of speakers requesting to speak.

If you cannot attend, you may submit a written statement to Ms. Clifford that will be given to the committee members, and read aloud at the meeting (if time permits). Statements received by April 26, 2004 will be sent to the Committee before the meeting.
TIMES PROVIDED FOR THE SPEAKERS TO PRESENT:
On both May 3rd and May 4th:

10:30 AM and 11:00 AM and
2:30 PM to 3:00 PM
PLEASE NOTE, times are approximate.
Background materials for this meeting will be posted at the Oncologic Drug Advisory Committee Dockets webside at:
www.fda.gov/ohrms/dockets/ac/acmenu.htm.
Click on the year 2004 and scroll down to the Oncologic Drugs Advisory Committee meetings. The background materials for May 3 topics will be posted by May 2. The background materials for the May 4 topics will be posted by May 3. For general information, please contact

JoAnn Minor
Phone: 301-827-4460
E-Mail: JMinor@oc.fda.gov
We hope you will join us for this meeting at:
The Hilton Hotel
The Ballrooms
620 Perry Parkway
Gaithersburg, Maryland
301-977-8900


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