# Oncologic Drugs Advisory Committee; Amendment of Notice
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice.
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: *[email protected]* , 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:
*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.