E6-5413. Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 June 2, 2006, from 10 a.m. to 2 p.m.

Location: Omni Hotel at CNN Center, International Ballroom, 100 CNN Center, Atlanta, Georgia. The hotel phone number is 404-659-0000.

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: [phone], e-mail: [e-mail], 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.

Agenda: The committee will discuss new drug application (NDA) 21-986, proposed trade name SPRYCEL (dasatinib) tablets, Bristol-Myers Squibb Co., with proposed indications for the: (1) Treatment of adults with chronic, accelerated, or blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib and (2) treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia, and lymphoid blast chronic myeloid leukemia with resistance or intolerance to prior therapy.

Procedure: 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 May 18, 2006. Oral presentations from the public will be scheduled between approximately 12 noon and 1 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 18, 2006, 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 least 7 days in advance of the meeting.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: April 5, 2006.

Jason Brodsky,

Acting Associate Commissioner for External Relations.