The FDA has approved a new treatment option for certain patients with biliary tract cancer (BTC), a rare and aggressive type of cancer that affects the bile ducts.
This new medication, called Ziihera (zanidatamab-hrii), is specifically for adults who have:
- HER2-positive biliary tract cancer
- Cancer that cannot be surgically removed or has spread to other parts of the body, and
- Previously received treatment for their cancer.
Ziihera is a bispecific HER2-directed antibody. It is the first treatment of its kind approved for biliary tract cancer in the United States. The FDA also approved a companion diagnostic device to aid in identifying patients with BTC who may be eligible for treatment with Ziihera.
Ziihera showed promising results in a clinical trial called HERIZON-BTC-01. About half of the patients (52%) who received Ziihera experienced an objective response. For those who responded to the treatment, the benefits lasted about 15 months on average. These results led the FDA to give Ziihera a special “accelerated approval.” This means patients can access the treatment sooner, while researchers continue to study its long-term benefits.
Side Effects: The most common side effects include diarrhea, reactions during the infusion, abdominal pain, and fatigue. The prescribing information contains a boxed warning for embryo-fetal toxicity.
This approval offers a new, targeted treatment option for patients with HER2-positive biliary tract cancer who have limited choices after initial treatment. If you have this type of cancer, discuss with your oncologist whether Ziihera might be appropriate for you.
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References:
Harding JJ, Fan J, Oh DY, et al; HERIZON-BTC-01 study group. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study. Lancet Oncol. 2023 Jul;24(7):772-782.
