[Federal Register: February 4, 2005 (Volume 70, Number 23)]
[Notices]
[Page 6016]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04fe05-96]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 March 3, 2005, from 8
a.m. to 5 p.m. and March 4, 2005, from 8 a.m. to 1 p.m.
Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD.
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: cliffordj@cder.fda.gov, 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: On March 3, 2005, the committee will do the following: (1)
Discuss new drug application (NDA) 21-115, COMBIDEX (ferumoxtran-10),
Advanced Magnetics, Inc., proposed indication for intravenous
administration as a magnetic resonance imaging contrast agent to assist
in the differentiation of metastatic and nonmetastatic lymph nodes in
patients with confirmed primary cancer who are at risk for lymph node
metastases, and (2) discuss prostate cancer endpoints as a followup to
the June 2004 FDA workshop. On March 4, 2005, the committee will do the
following: (1) Discuss the results of a confirmatory trial for NDA 21-
399, IRESSA (gefitinib) AstraZeneca Pharmaceticals LP, for the
treatment of patients with locally advanced or metastatic nonsmall cell
lung cancer after failure of both platinum-based and docetaxel
chemotherapies, and (2) discuss safety concerns, specifically
osteonecrosis of the jaw (ONJ), associated with two bisphosphonates,
NDA 21-223, ZOMETA (zoledronic acid) Injection and AREDIA (pamidronate
disodium for injection), both from Novartis Pharmaceuticals Corp.
ZOMETA is indicated for the treatment of patients with multiple myeloma
and patients with documented bone metastases from solid tumors, in
conjunction with standard antineoplastic therapy. Prostate cancer
should have progressed after treatment with at least one hormonal
therapy. It is also approved for hypercalcemia of malignancy. AREDIA is
indicated, in conjunction with standard antineoplastic therapy, for the
treatment of osteolytic bone metastases of breast cancer and osteolytic
lesions of multiple myeloma. It is also indicated for the treatment of
moderate or severe hypercalcemia associated with malignancy, and
treatment of patients with moderate to severe Paget's disease of bone.
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 February 28,
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 March
3, 2005, and between approximately 10:30 a.m. to 11 a.m. on March 4,
2005. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before February 28, 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 Trevelin Prysock at
301-827-7001, 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: January 27, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-2208 Filed 2-3-05; 8:45 am]
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