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

2.      New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval Final Rule; 21 Code of Federal
Regulations (CFR), Parts 314 and 601.

3.      Clinton W, Gore A. Reinventing the Regulation of Cancer Drugs. National performance review. March 1996.

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

of the IL-2 receptor

c.      DepoCyt® (cytarabine liposome injection) – approved Apr 1, 1999
Indication: for the intrathecal treatment of lymphomatous meningitis

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.


f.        Campath® (alemtuzumab) – approved May 7, 2001 Indication: for the
treatment of patients with B-cell chronic lymphocytic leukemia
who have been treated with alkylating agents and who have failed fludarabine therapy


g.     Bibliography