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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