[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