FDA’s Oncologic Drugs Advisory Committe hearing in Washington, DC on Abbott Lab’s application for approval of Xinlay (Atrasentan) will be held Sept 13. Details for this and other drug applications scheduled for hearings on 13th and 14th, below.

Center: CDER

Date and time:
September 13, 2005, 8:00 a.m. – 5:00 p.m.
September 14, 2005, 8:00 a.m. – 5:00 p.m.

Location:
Holiday Inn
The Ballrooms
8120 Wisconsin Ave.
Bethesda, MD

Open Public Hearing: Oral presentations from the public will be scheduled
between approximately 10:30 a.m. to 11 a.m., and 2:30 p.m. to 3 p.m. on both
September 13 and 14, 2005.

Agenda:
On September 13, 2005, the committee will discuss the following: (1) new drug application (NDA) 21-491, proposed trade name XINLAY (atrasentan hydrochloride) Capsules, Abbott Laboratories, proposed indication for the treatment of men with metastatic hormone-refractory prostate cancer; and (2) NDA 21-743, S003, TARCEVA (erlotinib) TABLETS, OSI Pharmaceuticals Inc., proposed indication for the first-line treatment, in combination with gemcitabine, of patients with locally advanced, unresectable or metastatic
pancreatic cancer.

On September 14, 2005, the committee will discuss the following: (1) NDA 21-880, proposed trade name REVLIMID (lenalidomide), Celgene Corp., proposed indication for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; and (2) NDA 21-877, proposed trade name ARRANON (nelarabine) Injection, GlaxoSmithKline, proposed indication for the treatment of
patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to, or has relapsed with, at least two chemotherapy regimens.

Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).

Procedure (Open Public Hearing):
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 by September 2, 2005. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m., and 2:30 p.m. to 3 p.m. on both days. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before September 2, 2005, 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. 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 Johanna Clifford at 301-827-7001, at least 7 days in advance of the meeting.

Contact Person:
Johanna M. Clifford, 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, 301-827-7001, FAX: 301-827-6776, e-mail: [email protected]

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting,
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512542.