Tesetaxel: SPA received

Genta said it reached an agreement with FDA on an SPA and received scientific advice from EMA for a Phase III trial to evaluate tesetaxel as a single agent in metastatic breast cancer patients. The company said the agencies confirmed tesetaxel can be compared with another commonly used oral agent and that PFS, rather than overall survival (OS), will be used as a primary endpoint. Genta will determine the timeline for starting the trial following initial results from an ongoing Phase IIb trial comparing tesetaxel vs. Xeloda capecitabine in first-line treatment of recurrent or metastatic breast cancer (see BioCentury, June 11). ...