Posted by Michael Wonder on 03 Apr 2024
Zanidatamab biologics license application for previously treated HER2 positive metastatic biliary tract cancer completed
2 April 2024 - Zymeworks is pleased to announce, along with our partners Jazz Pharmaceuticals, completion of the rolling submission of a biologics license application to the US FDA seeking accelerated approval for the HER2 targeted bispecific antibody zanidatamab as a treatment for previously treated, unresectable, locally advanced, or metastatic HER2 positive biliary tract cancer.
If approved, zanidatamab would be the first HER2 targeted treatment specifically approved for biliary tract cancer in the US.
