FDA Urgency To Clear TLC Evacet May Be Lessened By Ellence Approval
Executive Summary
The impetus for FDA to approve The Liposome Company's Evacet (liposomal doxorubicin, D-99), based on incomplete efficacy data may be lessened by the recent U.S. approval of Pharmacia & Upjohn's Ellence (epirubicin).
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The Liposome Company Moves Past Evacet Set-Backs With Elan Merger
Elan would add a 40 rep oncology sales force to market its non-opioid analgesic ziconotide with the acquisition of The Liposome Company announced March 6.
The Liposome Company's Evacet
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)