Document ID: FDA-2010-N-0001-0159
Agency: fda
Document Type: Notice
Title: Oncologic Drugs Advisory Committee; Cancellation
Posted Date: 2010-12-27T05:00Z

[Federal Register Volume 75, Number 247 (Monday, December 27, 2010)]
[Notices]
[Page 81283]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32413]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Oncologic Drugs Advisory Committee; Cancellation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The meeting of the Oncologic Drugs Advisory Committee 
scheduled for February 9, 2011, is cancelled. This meeting was 
announced in the Federal Register of December 6, 2010 (75 FR 75680). On 
February 9, 2011, the Oncologic Drugs Advisory Committee was scheduled 
to discuss biologics license application (BLA) 125377, with the 
proposed trade name YERVOY (ipilimumab), submitted by Bristol-Myers 
Squibb Co. The proposed indication (use) for this product is for the 
treatment of advanced melanoma in patients who have received prior 
therapy. This meeting has been cancelled because the issues for which 
FDA was seeking the scientific input of the committee have been 
resolved.

FOR FURTHER INFORMATION CONTACT: Nicole Vesely, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, e-mail: Nicole.vesely@fda.hhs.gov, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), and follow the prompts to the desired center 
or product area. Please call the Information Line for up-to-date 
information on this meeting.

    Dated: December 21, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-32413 Filed 12-23-10; 8:45 am]
BILLING CODE 4160-01-P