Oncologic Drugs Advisory Committee Meeting
November 8, 2005
Briefing Material
Table of
Contents
1. Memo from
Richard Pazdur, M.D., Director, Office of Oncology Drug Products
4. Accelerated Approval letters for 6 sponsors that are
presenting:
a.
Doxil® (doxorubicin HCl liposome
injection) – approved Nov 17, 1995
Indication: for the treatment of AIDS-related
Kaposi’s sarcoma in patients with
disease that has progressed on prior combination
chemotherapy or
in patients who are intolerant to such therapy
b. Ontak® (denileukin diftitox) –approved
Feb 5, 1999
Indication:
for the treatment of patients with persistent or recurrent cutaneous
T-cell
lymphoma (CTCL) whose malignant cells express the CD25 component
d. Celebrex® (celecoxib) capsules – approved Dec 23, 1999
Indication: to
reduce the number of adenomatous colorectal polyps in Familial
Adenomatous
Polyposis (FAP) patients, as an adjunct to usual care
(e.g., endoscopic surveillance, surgery)
e.
Mylotarg® (gemtuzumab ozogamicin for
Injection) – approved May 17, 2000
Indication:
for the treatment of patients with CD33 positive acute myeloid
leukemia (AML)
in first relapse who are 60 years of age or older and who are
not considered
candidates for other cytotoxic chemotherapy.
g. Bibliography