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# Athenex NDA for Breast Cancer Drug
- URL: https://www.fdaweb.com/athenex-nda-for-breast-cancer-drug/
- Published: 2020-09-03T12:00:00.000Z
- Updated: 2026-09-14T16:27:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147586

FDA has accepted for priority review an Athenex NDA for oral paclitaxel and encequidar for treating metastatic breast cancer. The submission is supported by data from a single pivotal Phase 3 study. The company [previously reported](https://www.globenewswire.com/Tracker?data=iUQ4gEYvGHcY6fV0kqN2-TDH2csZImiq91eR3UTYhU4X24HwGHsnyuiTbKP9GfgoOAMdeOIKt-N%5FtsYaMJnFi3CLwJzQjq8dO-4Qli3TmomjD0e25qgpbfj2IomCz2D7d7%5FKw0I0tEKyk4PbFtyPNnfZbQtRhnsHgEhWB9iLRHyaawqCmPQYo5W-IEMOHdvS%5FXTFyum1wd3WtPRQfiHOmw==&ref=fdaweb.com) that the study achieved its primary endpoint by showing statistically significant improvement in overall response rate, along with a lower neuropathy, for oral paclitaxel compared to intravenous paclitaxel. The agency has set a user fee review action target date of 2/28/2021.