Posted by Michael Wonder on 01 Mar 2021
Athenex receives FDA complete response letter for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer
1 March 2021 - Athenex today announced that the U.S. FDA has issued a complete response letter for the company’s new drug application for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer.
In the complete response letter, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the oral paclitaxel arm compared with the IV paclitaxel arm.
