Posted by Michael Wonder on 01 Sep 2020
Athenex announces FDA acceptance for filing of U.S. NDA for oral paclitaxel and encequidar in metastatic breast cancer with priority review
1 September 2020 - FDA grants priority review and sets PDUFA target action date of 28 February 2021.
Athenex today announced that the U.S. FDA has accepted for filing the Company’s new drug application for oral paclitaxel and encequidar (oral paclitaxel) for the treatment of metastatic breast cancer and has granted the application priority review.
Additionally, the FDA has communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
