Posted by Michael Wonder on 12 Jul 2022
FDA accepts Byondis' biologics license application for [vic-] trastuzumab duocarmazine (SYD985) in HER2 positive metastatic breast cancer
12 July 2022 - Submission follows positive results of Phase 3 TULIP trial.
Byondis announced today that the U.S. FDA accepted the company's submission of a biologics license application for [vic-] trastuzumab duocarmazine (SYD985) in patients with HER2 positive unresectable locally advanced or metastatic breast cancer.
The company has been given a Prescription Drug User Fee Act action date of 12 May 2023.
