The Liposome Company's Evacet

Executive Summary

NDA for liposomal doxorubicin may be resubmitted as early as the end of the year, the company says after withdrawing its application for treatment of metastatic breast cancer Oct. 14. The company will provide FDA with a subgroup analysis of patients at high risk for cardiac damage from doxorubicin, including the elderly and women with decreased cardiac function. TLC estimates that up to one-third of metastatic breast cancer patients fit the narrower indication. The Oncologic Drugs Advisory Committee recommended against approval based on unclear efficacy compared with epirubicin (1"The Pink Sheet" Sept. 27, p. 6)