Document ID: FDA-2010-N-0001-0146
Agency: fda
Document Type: Notice
Title: Meetings: Oncologic Drugs Advisory Committee; Amendment
Posted Date: 2010-11-23T05:00Z

[Federal Register Volume 75, Number 225 (Tuesday, November 23, 2010)]
[Notices]
[Page 71450]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29522]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Oncologic Drugs Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of a meeting of the Oncologic Drugs Advisory 
Committee. This meeting was announced in the Federal Register of 
October 19, 2010 (75 FR 64314). The amendment is being made to reflect 
changes in the Date and Time, Agenda, and Procedure portions of the 
document. We also are postponing a session regarding biologics license 
application (BLA) 125377, with the proposed trade name Yervoy 
(ipilimumab), manufactured 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 portion of 
the meeting has been postponed due to the need to complete the review 
of additional data submitted by the applicant. Future meeting dates may 
be announced in the Federal Register.

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, code 301-451-2542. Please call the Information 
Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 19, 2010 
(75 FR 64314), FDA announced that a meeting of the Oncologic Drugs 
Advisory Committee would be held on December 2, 2010. On page 64314, in 
the first column, the Date and Time portion of the document is changed 
to read as follows:
    Date and Time: The meeting will be held on December 2, 2010, from 8 
a.m. to 12:30 p.m.
    On page 64314, in the second column, the Agenda portion of the 
document is changed to read as follows:
    Agenda: On December 2, 2010, the committee will discuss new drug 
application (NDA) 022-405, with the proposed trade name Zictifa 
(vandetanib) Tablets, manufactured by iPR Pharmaceuticals, Inc., 
represented by AstraZeneca Pharmaceuticals LP (authorized U.S. agent). 
The proposed indication (use) for this product is for the treatment of 
patients with unresectable (non-operable) locally advanced or 
metastatic medullary thyroid cancer.
    On page 64314, in the second column, the third sentence in the 
Procedure portion of the document is changed to read as follows:
    Procedure: Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. and 11:30 a.m.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: November 17, 2010.
Joanne Less,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-29522 Filed 11-22-10; 8:45 am]
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