Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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)

You may also be interested in...



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).

Related Content

UsernamePublicRestriction

Register

PS035021

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel