BioCentury
ARTICLE | Regulation

Liposome's bad day at ODAC

September 20, 1999 7:00 AM UTC

WASHINGTON - At its Oncologic Drugs Advisory Committee hearing for Evacet as a first-line treatment of metastatic breast cancer, the Liposome Co. Inc. last week was set upon by FDA officials who attacked key aspects of its clinical trials and ODAC members who rejected the basic premises of the clinical development program the company and FDA agreed on five years ago.

Evacet is a liposomal version of doxorubicin, a widely prescribed chemotherapy that can cause serious or fatal heart damage. Providing doxorubicin a liposome coating was intended to limit uptake of the drug by cardiac tissues. LIPO's strategy was premised on the assumption that because doxorubicin is widely prescribed, the main hurdle to winning marketing approval would be demonstrating a superior safety profile...