Food and Drug Administration

Oncologic Drugs Advisory Committee

June 7, 1999



The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Considerations on the Unse of TTP as the Primary Efficacy Endpoint in RCTs of Cytotoxic Drugs for Initial Rx of MBC, Dr. John Johnson, MD  htm  ppt

Should TTP be a Primary Efficacy Endpoint for First Line Chemotherapy Trials in Metastatic Breast Cancer, Dr. Sandra Swain, MD  pdf

Epirubicin (Epirubicin Hydrochloride), Pharmacia & Upjohn  htm  ppt

NDA 21-010 (NDA 50-778) Epirubicin Hydrochloride Pharmacia & Upjohn, Dr. Susan Honig, MD  htm  ppt