March 22, 2010: Oncologic Drugs Advisory Committee Meeting Announcement
(This meeting is a re-schedule of the February 10, 2010, postponed ODAC meeting).
|CDER||March 22, 2010
||8:00 a.m. - 5:00 p.m.
||Hilton Washington DC North/Gaithersburg
620 Perry Parkway
The March 22, 2010 Oncologic Drugs Advisory Committee meeting is a reschedule of a postponed meeting originally announced in the FEDERAL REGISTER of December 17, 2009 (74 FR 66986) to take place on February 10, 2010.
On March 22, 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.
Due to the postponement of the February 10, 2010, Oncologic Drugs Advisory Committee meeting because of severe weather conditions and the urgency to reschedule this meeting, FDA regrets that it was unable to publish this notice 15 days prior to the March 22, 2010, Oncologic Drugs Advisory Committee meeting. Because the agency believes there is some urgency to bring these issues to public discussion and because of the availability of qualified members of the Oncologic Drugs Advisory Committee on this date, the Commissioner of Food and Drugs concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice.
Background materials from the originally scheduled February 10, 2010, Oncologic Drugs Advisory Committee meeting are currently available at: 2010 Meeting Materials, Oncologic Drugs Advisory Committee. Should any additional background materials become available, they will be posted two days ahead of the March 22, 2010 meeting at this same Web site.
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 March 17, 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. on March 22nd. 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 March 12, 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 March 15, 2010.
- 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
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
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.
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).