Document ID: FDA-2009-N-0664-0125
Agency: fda
Document Type: Notice
Title: Meetings: Oncologic Drugs Advisory Committee
Posted Date: 2009-12-08T05:00Z

[Federal Register: December 8, 2009 (Volume 74, Number 234)]
[Notices]               
[Page 64701-64702]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08de09-41]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
Oncologic Drugs Advisory Committee; Amendment of Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    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 November 17, 2009 
(74 FR 59195). The amendment is being made to reflect a change in the 
Date and Time, Agenda, and Procedure portions of the document. We also 
are cancelling a session regarding supplemental new drug application 
(sNDA) 022-059/S-007, TYKERB (lapatinib) tablets, by SmithKline Beecham 
Ltd. d/b/a GlaxoSmithKline. This portion of the 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 (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093), 
Rockville, MD 20857, 301-827-6793, FAX: 301-827-6776, 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 
3014512542. Please call the Information Line for up-to-date information 
on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 17, 2009 
(74 FR 59195), FDA announced that a meeting of the Oncologic Drugs 
Advisory Committee would be held on December 16, 2009. On page 59195, 
in the first column, the Date and Time portion of the document is 
changed to read as follows:

[[Page 64702]]

    Date and Time: The meeting will be held on December 16, 2009, from 
9 a.m. to 3 p.m.
    On page 59195, in the second column, the Agenda portion of the 
document is changed to read as follows:
    Agenda: On December 16, 2009, the committee will discuss 
supplemental new drug application (sNDA) 021-743/S-016, TARCEVA 
(erlotinib) tablets, by OSI Pharmaceuticals, Inc. The proposed 
indication (use) for this product is first-line maintenance, 
monotherapy (first-choice, single drug) treatment in patients with a 
form of lung cancer called non-small cell lung cancer (NSCLC) that is 
either locally advanced (has spread regionally within the lung and/or 
within chest lymph nodes) or metastatic (has spread beyond the lung), 
and who have not progressed (including those patients with stable 
disease) on first-line treatment with platinum-based chemotherapy (a 
regimen including a platinum drug (cisplatin or carboplatin) plus 
another chemotherapy drug).
    On page 59195, in the third 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 1 p.m. to 2 p.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: December 3, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-29208 Filed 12-7-09; 8:45 am]

BILLING CODE 4160-01-S