Posted by Michael Wonder on 06 Jul 2021
Athenex provides update from FDA Type A meeting regarding oral paclitaxel plus encequidar for the treatment of metastatic breast cancer
6 July 2021 - Athenex today announced that the Company held a Type A meeting with the U.S. FDA during the second quarter of 2021 to discuss the deficiencies raised in the complete response letter received in February.
At the meeting, Athenex provided additional analyses, including overall survival data on patient subgroups, to provide a more comprehensive summary of the risk/benefit assessment.
Athenex also proposed to collect additional overall survival data that could inform the design of a new clinical trial.
