ZIIHERA is a promising new medication for adults with HER2-positive biliary tract cancer (BTC) that has already been treated but is still progressing. This type of cancer affects the bile ducts or gallbladder, and ZIIHERA offers hope for patients who have limited options. ZIIHERA was approved on November 20, 2024.
What is the name of the drug, and what does it do?
ZIIHERA (pronounced zye-HAYR-rah) is the brand name for zanidatamab-hrii. It is designed specifically for people with a type of cancer that has a high amount of a protein called HER2. This protein can make cancer cells grow and spread quickly. ZIIHERA works by blocking HER2, which helps to slow down the cancer and even destroy the cancer cells.
How does it work?
ZIIHERA is a “bispecific HER2 antibody.” This means it is a specialized protein that attaches to two different parts of the HER2 protein on cancer cells. Once attached, it sends signals to your immune system to attack the cancer cells and break them down. By reducing HER2 on the surface of these cells, it helps stop the cancer from growing further.
What did the research discover?
In a clinical trial called HERIZON-BTC-01, ZIIHERA was tested on 62 patients with HER2-positive biliary tract cancer (BTC). The results showed that 52% of patients experienced significant tumor shrinkage. Among those who responded to the treatment, 59% maintained their results for at least six months, and 44% for 12 months. On average, the response lasted approximately 14.9 months, offering a hopeful outcome for patients with limited treatment options.for a meaningful period.
What are some of the side effects?
Like all medications, ZIIHERA may cause side effects. The most common ones include:
- Diarrhea (50% of patients; severe in 10%)
- Infusion-related reactions such as fever, chills, or nausea (35%)
- Abdominal pain (29%)
- Fatigue (24%)
- Nausea and vomiting
While less common, severe side effects like decreased heart function and serious infections can occur. It’s important to work closely with your doctor to manage side effects.
What are the dosage recommendations, and how is it prescribed?
ZIIHERA is given as an intravenous (IV) infusion every two weeks. Before each infusion, patients are given medications like acetaminophen and antihistamines to reduce the chance of a reaction. The first two infusions take 120–150 minutes, but if they go well, later infusions may take as little as 60 minutes. Treatment continues until the cancer progresses or side effects become unmanageable.
Source
Jazz Pharmaceuticals, Inc. Prescribing information for ZIIHERA (zanidatamab-hrii). November 2024. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761416s000lbl.pdf
