|CDER||February 8, 2011||8:00 a.m. to 5:00 p.m.||FDA White Oak Campus|
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
The committee will hear updates on new drug applications (NDAs) and biologics license applications (BLAs) approved under 21 CFR 314.500 and 601.40 (subpart H and subpart E, respectively, accelerated approval regulations) prior to January 1, 2009. These updates will provide information related to the status of phase IV clinical studies and to difficulties associated with completion of phase IV commitments. Phase IV studies are postmarketing studies to confirm clinical benefit of a drug after it receives accelerated approval.
Specifically, the committee will receive updates on the following products: (1) BLA 125084, trade name ERBITUX (cetuximab), application submitted by Imclone Systems Inc., used in combination with the anticancer agent irinotecan and indicated for the treatment of epidermal growth factor receptor (EGFR)-expressing colorectal cancer that has metastasized (spread beyond the colon or rectum) in patients for whom chemotherapy using irinotecan alone is ineffective or less effective; (2) supplemental BLA (sBLA) 125011/24, trade name BEXXAR (tositumomab and Iodine I 131 tositumomab), application submitted by SmithKline Beecham Corp. doing business as (d/b/a) GlaxoSmithKline, indicated for the treatment of patients with varieties of non-Hodgkin’s lymphoma known as CD20 antigen-expressing relapsed or refractory, low grade, follicular, or transformed non-Hodgkin's lymphoma, who have not received the drug Rituximab; (3) NDA 21-673, tradename CLOLAR (clofarabine) for intravenous infusion, application submitted by Genzyme Corp., indicated for the treatment of pediatric patients 1 to 21 years old with acute lymphoblastic leukemia (ALL) whose disease has not responded to or has relapsed following treatment with at least two prior chemotherapy regimens; (4) NDA 21-877, tradename ARRANON (nelarabine) Injection, application submitted by GlaxoSmithKline, indicated for the treatment of patients with types of leukemia or lymphoma known as T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens; (5) BLA 125147, tradename VECTIBIX (panitumumab), application submitted by Amgen Inc., indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens; and (6) sNDA 21-588/025, tradename GLEEVEC (imatinib mesylate) tablets, application submitted by Novartis Pharmaceuticals Corp., indicated for the adjuvant (additional) treatment of adult patients following complete gross resection (removal) of a form of cancer known as Kit (CD117) positive gastrointestinal stromal tumors (GIST).
Based on the updates provided, the committee will have a general discussion centering on possible ways to improve the planning and conduct of trials to confirm clinical benefit (post marketing requirements). The overall goal will be the optimization of the accelerated approval process with a focus on decreasing the amount of time to confirm (or fail to confirm) clinical benefit while continuing to provide early availability of promising oncology products.
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.
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 January 25, 2010.
- Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 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 14, 2011.
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 18, 2011.
- Nicole Vesely, Pharm.D.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
- 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 Web site 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) 796-9001 at least 7 days in advance of the meeting.
Information regarding special accommodations due to a disability, visitor parking and transportation may be accessed at White Oak Conference Center Parking and Transportation Information for FDA Advisory Committee Meetings.
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Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).