FDA Approves Zanidatamab for Advanced HER2-Positive Biliary Tract Cancer

The accelerated approval of Jazz Pharmaceuticals' Ziihera® offers a new chemotherapy-free treatment option for patients with limited alternatives.

Ziihera® (zanidatamab-hrii) has received FDA accelerated approval for adults with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer.
The approval is based on a 52% objective response rate and a median duration of response of 14.9 months observed in the Phase 2B HERIZON-BTC-01 trial.
Ziihera is the first dual HER2-targeted bispecific antibody treatment for this condition, providing a chemotherapy-free option for patients with few alternatives.
Biliary tract cancer includes gallbladder cancer and cholangiocarcinoma, with HER2 overexpression rates varying by cancer type; survival rates for metastatic cases remain under 5%.
A Phase 3 trial, HERIZON-BTC-02, is underway to confirm the therapy's clinical benefits and evaluate its use in first-line treatment settings.