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Notice

Oncologic Drugs Advisory Committee; Cancellation

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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.

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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.

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Dated: December 21, 2010.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.

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[FR Doc. 2010-32413 Filed 12-23-10; 8:45 am]

BILLING CODE 4160-01-P