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)
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The Liposome Company Evacet
Additional clinical data will be needed to gain FDA approval for metastatic breast cancer based on discussions with FDA, company says Feb. 3. The company is considering foregoing the metastatic indication in favor of pursuing a lymphoma indication. The company had submitted analyses to FDA to support resubmission of the Evacet application following withdrawal of the original application (1"The Pink Sheet" Oct. 18, 1999, In Brief)
The Liposome Company Evacet
Additional clinical data will be needed to gain FDA approval for metastatic breast cancer based on discussions with FDA, company says Feb. 3. The company is considering foregoing the metastatic indication in favor of pursuing a lymphoma indication. The company had submitted analyses to FDA to support resubmission of the Evacet application following withdrawal of the original application (1"The Pink Sheet" Oct. 18, 1999, In Brief)
FDA Urgency To Clear TLC Evacet May Be Lessened By Ellence Approval
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).