Document ID: FDA-2009-N-0664-0127
Agency: fda
Document Type: Notice
Title: Oncologic Drugs Advisory Committee; Notice of Meeting
Posted Date: 2009-12-17T05:00Z

[Federal Register: December 17, 2009 (Volume 74, Number 241)]
[Notices]               
[Page 66986-66987]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17de09-57]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 10, 2010, from 
8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy, Gaithersburg, MD. The hotel phone number is 301-977-
8900.
    Contact Person: Nicole Vesely, Pharm.D., 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. A notice in the Federal Register about last minute 
modifications that impact a previously announced advisory committee 
meeting cannot always be published quickly enough to provide timely 
notice. Therefore, you should always check the agency's Web site and 
call the appropriate advisory committee hot line/phone line to learn 
about possible modifications before coming to the meeting.
    Agenda: On February 10, 2010, during the morning session, the 
committee will discuss new drug application (NDA) 022-481, proposed 
trade name PIXUVRI (pixantrone dimaleate) injection, manufactured by 
Cell Therapeutics, Inc. The proposed indication (use) for this product 
is as a single agent treatment for patients with recurring or 
refractory (difficult to treat), aggressive non-Hodgkin's lymphoma 
(NHL) who have received two or more prior lines of therapy.
    During the afternoon session, the committee will discuss NDA 022-
374, proposed trade name OMAPRO (omacetaxine mepesuccinate) for 
injection, manufactured by ChemGenex Pharmaceuticals. The proposed 
indication (use) for this product is for the treatment of adults with 
chronic myeloid leukemia (CML) bearing a genetic alteration known as 
the Bcr-Abl T315I mutation, and who have failed prior therapy with the 
drug IMATINIB.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written

[[Page 66987]]

submissions may be made to the contact person on or before January 27, 
2010. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. Those 
desiring to make formal oral presentations should notify the contact 
person and submit a brief statement of the general nature of the 
evidence or arguments they wish to present, the names and addresses of 
proposed participants, and an indication of the approximate time 
requested to make their presentation on or before January 19, 2010. 
Time allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by January 20, 2010.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Nicole Vesely at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 11, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-29989 Filed 12-16-09; 8:45 am]

BILLING CODE 4160-01-S