Food and Drug Administration

Food and Drug Administration

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

62^nd Meeting

Town Center Hotel

Silver Spring, Maryland

Tentative Agenda June 7-8, 1999

9:30 Call to Order and Opening Remarks Janice Dutcher, M.D.
Chair, ODAC

Introduction of Committee

Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Executive Secretary, ODAC

9:45 Open Public Hearing

Is Time-to-Progression an acceptable primary efficacy endpoint in breast cancer

or is survival the only acceptable primary endpoint?

10:15 Presentations John R. Johnson, M.D.
Medical Officer, FDA

Sandra Swain, M.D.
ODAC Consultant

11:00 Break

11:15 Committee Discussion and Vote

12:30 Lunch

June 7, 1999 – Afternoon Session

1:30 Open Public Hearing

NDA 21-010, epirubicin hydrochloride for injection, Pharmacia and Upjohn Company

indicated for use as a component of adjuvant therapy in patients with evidence of axillary-node-tumor involvement following resection of primary breast cancer (Stage II & III). Epirubicin is indicated for the therapy of patients with locally advanced or metastatic breast cancer.

1:45 Sponsor Presentation Pharmacia & Upjohn Company

Randomized, well-controlled studies Langdon L. Miller, M.D.
supporting approval of epirubicin hydrochloride Vice President
as adjuvant therapy for early breast cancer and Clinical Development Oncology
as therapy for advanced disease Pharmacia and Upjohn Company

2:45 Questions from the Committee

3:15 Break

3:30 FDA Presentation Susan Honig, M.D.
FDA Reviewer

4:30 Questions from the Committee

5:00 Committee Discussion and Vote

5:30 Adjourn

June 8, 1999 - Morning Session

8:00 Call to Order and Opening Remarks Janice Dutcher, M.D.
Chair, ODAC

Introduction of Committee

Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Executive Secretary, ODAC

8:15 Open Public Hearing

NDA 50-718/S-006, Doxil® (doxorubicin HCl liposome injection), ALZA Corporation

indicated for the treatment of patients with metastatic carcinoma of the ovary who are refractory to both paclitaxel- and platinum-based chemotherapy regimens and who may also be refractory to topotecan. Refractory is defined as a patient having progressive disease while on treatment, or within 6 months of completing treatment.

8:30 Sponsor Presentation ALZA Corporation

Introduction Edward Schnipper, MD

Unmet Medical Need in Maurie Markman, MD

Advanced Metastatic Ovarian Cancer The Cleveland Clinic

STEALTH™ Liposome Background Frank Martin, PhD
and Doxil Pharmacology

Doxil Efficacy in Advanced Metastatic Edward Schnipper, MD
Ovarian Cancer

Doxil Safety Review Ken Cunningham, MD

Concluding Remarks Edward Schnipper, MD

9:30 Questions from the Committee

10:00 Break

10:15 FDA Presentation Gregory Frykman, M.D.
FDA Reviewer

11:15 Questions from the Committee

11:45 Committee Discussion and Vote

12:15 Lunch

June 8, 1999 - Afternoon Session

1:15 Open Public Hearing

NDA 20-221/S-012, Ethyol® (amifostine) for injection, U.S. Bioscience, Inc.

indicated for use to reduce the incidence and severity of radiation induced xerostomia

1:30 Sponsor Presentation U.S. Bioscience, Inc.

2:30 Questions from the Committee

3:00 Break

3:15 FDA Presentation Isagani Chico, M.D.
FDA Reviewer

4:15 Questions from the Committee

4:45 Committee Discussion and Vote

ODAC Discussants Andrew Harwood, M.D.
ODAC Consultant

Scott Lippman, M.D.
ODAC Consultant

5:15 Adjourn