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March 12-13, 2003 Final Agenda

[Federal Register: October 28, 2005 (Volume 70, Number 208)]
[Notices]               
[Page 62126]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc05-49]                         


[[Page 62126]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Oncologic Drugs Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of the meeting of the Oncologic Drugs Advisory Committee. 
This meeting was announced in the Federal Register of October 14, 2005 
(70 FR 60094). The amendment is being made to reflect changes in the 
Agenda portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Johanna 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 or email:
cliffordj@cder.fda.gov.


SUPPLEMENTARY INFORMATION: In the Federal Register of October 14, 2005, 
FDA announced that a meeting of the Oncologic Drugs Advisory Committee 
will be held on November 8, 2005. On page 60094, beginning in the third 
column, and continuing on page 60095, the Agenda portion of the meeting 
is amended to read as follows:
    Agenda: The committee will discuss new drug applications approved 
under 21 CFR 314.500 and 601.40 (subparts H and subpart E, 
respectively, accelerated approval regulations) in an open session to 
do the following: (1) Review the status of phase IV clinical studies; 
(2) identify difficulties associated with completion of phase IV 
commitments; and (3) provide advice to sponsors to assist in the 
planning and execution of postmarketing commitments of newly approved 
drugs. The committee will discuss phase IV commitments of: (1) New drug 
application (NDA) 50-718, DOXIL (doxorubicin hydrochloride liposome 
injection, Johnson and Johnson Pharmaceutical Research and Development, 
L.L.C.) for the treatment of acquired immune deficiency syndrome (AIDS) 
related Kaposi's sarcoma in patients with disease that has progressed 
on prior combination therapy or in patients who are intolerant to such 
therapy; (2) biologics license application (BLA) 103767/0, ONTAK 
(denileukin diftitox, Seragen Incorporated) for the treatment of 
patients with persistent or recurrent cutaneous T-cell lymphoma whose 
malignant cells express the CD25 component of the interleukin-2 
receptor; (3) NDA 21-041, DEPOCYT (cytarabine liposome injection, 
SkyePharma Inc.) for the intrathecal treatment of lymphomatous 
meningitis; (4) NDA 21-156, CELEBREX (celecoxib capsules, Pfizer Inc.) 
for reducing the number of adenomatous colorectal polyps in familial 
adenomatous polyposis (FAP), as an adjunct to usual care (e.g., 
endoscopic surveillance, surgery); (5) NDA 21-174, MYLOTARG (gemtuzumab 
ozogamicin for injection, Wyeth Pharmaceuticals, Inc.) for the 
treatment of patients with CD33 positive acute myeloid leukemia in 
first relapse who are 60 years of age or older and who are not 
considered candidates for other cytotoxic chemotherapy; and (6) BLA 
103948/0, CAMPATH (alemtuzumab, ILEX Pharmaceuticals, L.P.) for the 
treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients 
who have been treated with alkylating agents and who have failed 
fludarabine therapy.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: October 21, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-21493 Filed 10-27-05; 8:45 am]

BILLING CODE 4160-01-S