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# Athenex Evaluating New Cancer Drug Trial
- URL: https://www.fdaweb.com/athenex-evaluating-new-cancer-drug-trial/
- Published: 2021-07-07T12:00:00.000Z
- Updated: 2026-09-14T17:05:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149655

Following a meeting with FDA officials to discuss deficiencies in a complete response letter issued for Athenex’ oral paclitaxel plus encequidar to treat metastatic breast cancer, the company says it is evaluating the best way to proceed with a new clinical study it wants to present to the agency in the fourth quarter. Athenex [says](https://ir.athenex.com/news-releases/news-release-details/athenex-provides-update-fda-type-meeting-regarding-oral?ref=fdaweb.com) it presented to FDA additional analyses, including overall survival data on patient subgroups, to provide a more comprehensive summary of the risk/benefit assessment for the drug. It also proposed collecting additional overall survival data that could inform the design of the new study.

According to the company, agency officials encouraged it to continue the development of the drug and agreed that a well-designed and well-conducted trial may adequately address the deficiencies raised in the letter.