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U.S. Department of Health and Human Services

Advisory Committees

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September 1, 2009: Oncologic Drugs Advisory Committee Meeting Announcement

CDERSeptember 1, 2009
8:00 a.m. - 5:00 p.m.
Hilton Washington DC/Silver Spring
The Ballrooms
8727 Colesville Road
Silver Spring, Maryland


On September 1, 2009, the committee will discuss (1) supplemental NDA (sNDA) 021-673/S-009, CLOLAR (clofarabine) Injection for intravenous use, Genzyme Corporation, proposed indication for the treatment of previously untreated adults aged 60 years or older with acute myeloid leukemia with at least one unfavorable baseline prognostic factor, and (2) New Drug Application (NDA) 022-489, proposed trade name ONRIGIN (laromustine) Injection, Vion Pharmaceuticals, Inc., proposed indication for remission induction therapy for patients 60 years or older with de novo poor-risk acute myeloid leukemia (AML).

CLOLAR (clofarabine) Injection for intravenous use has a new proposed indication for treatment of AML in previously untreated adults aged 60 years or older with at least one medical or health factor that increases the risk of an unfavorable outcome. Laromustine Injection, with the proposed trade name ONRIGIN, has a proposed use for “remission induction therapy” for acute myeloid leukemia (AML). This is an initial approach to AML treatment designed to induce, or bring about, remission (reduction or disappearance) of leukemia in patients 60 years or older with de novo, or first occurrence, AML designated as “poor-risk,” or more likely to have a poor outcome.

Meeting Materials

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

  • Written submissions may be made to the contact person on or before August 25, 2009.
  • Oral presentations from the public will be scheduled between approximately 10:45 a.m. - 11:15 a.m. and 3:30 p.m. - 4:00 p.m. on September 1.  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 August 25, 2009.

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 August 26, 2009.

Contact Information

  • 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
    Phone: 301-827-7001
    Fax: 301-827-6776
    E-mail:  Nicole.Vesely@fda.hhs.gov
  • FDA Advisory Committee Information Line
    (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 Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

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

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 (301) 827-7001 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 Public Conduct During FDA Advisory Committee Meetings 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).