FDA of­fers ‘break­through’ sta­tus for a HER2xHER2 bis­pe­cif­ic at the top of Zymeworks’ pipeline

Van­cou­ver-based Zymeworks just got a leg up in its quest to win an ac­cel­er­at­ed ap­proval for their lead drug: a HER2-tar­get­ed bis­pe­cif­ic dubbed zanidatam­ab in pa­tients with pre­vi­ous­ly-treat­ed HER2 gene-am­pli­fied bil­iary tract can­cer.

The FDA has pro­vid­ed their break­through ther­a­py des­ig­na­tion for the pro­gram, of­fer­ing an open door — or Zoom win­dow — in­to the agency as the biotech push­es through a Phase IIb tri­al.

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