Athenex’s Paclitaxel and Encequidar Combo Granted FDA Priority Review for Breast Cancer

The FDA has granted priority review to Athenex’s Oral Paclitaxel (oral paclitaxel and encequidar) for treating metastatic breast cancer.

The Buffalo, N.Y.-based company’s new drug application is supported by data from a phase 3 clinical trial in which Oral Paclitaxel as a monotherapy improved the response rate compared to intravenous paclitaxel. 

Athenex said the FDA has indicated that it won’t be holding an advisory committee meeting to discuss the application. The agency’s decision date for the drug is Feb. 28, 2021.