BioCentury
ARTICLE | Regulation

Reporter's notebook on ODAC

October 23, 1995 7:00 AM UTC

WASHINGTON - An FDA advisory committee meeting frequently raises many interesting and important issues that cannot be described fully in a one or two-page BioCentury Extra article focused on decisions taken at the meeting. Last week's Oncologic Drugs Advisory Committee's deliberations on Rhone Poulenc Rorer Inc.'s Taxotere and Immunomedics Inc.'s CEA-Scan were no exception.

Last December, ODAC voted to recommend against approval of Taxotere (docetaxel) as a treatment for breast and non-small cell lung cancer. Last week, the panel reversed itself, voting 6-1 for approval in the breast cancer indication...