Meetings:

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Federal Register: December 27, 2010 (Volume 75, Number 247)

Notices

Page 81283

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

DOCID:fr27de10-99

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.

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

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