[Federal Register Volume 75, Number 247 (Monday, December 27, 2010)]
[Notices]
[Page 81283]
From the Federal Register Online via the Government Publishing 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: [email protected], 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]
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