Key Summary
- MHRA has approved zanidatamab (Ziihera) for advanced bile duct cancer that cannot be removed by surgery.
- In a small study, about half of patients with high HER2 levels saw their tumours shrink or disappear, though it wasn’t compared with other treatments.
- The drug is given every two weeks, will be closely monitored for safety, and can cause side effects.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved zanidatamab (Ziihera) for biliary tract cancer that cannot be removed by surgery, and has spread to nearby tissues and body parts.
Zanidatamab is administered by an infusion drip into a vein every two weeks.
The approval was granted to Jazz Pharmaceuticals Research UK Limited, and this product was submitted and approved via the International Recognition Procedure.
Biliary tract cancer affects the bile ducts that stores and transport bile, and leads to high levels of protein called HER2 that drives tumour growth.
A small study consisting of 80 bile duct cancer patients for whom surgery was not an option was conducted.
The study revealed that the 52 per cent of the 62 patients with high levels of HER2 protein experienced shrinking or complete cure from their illness with nearly 34 months of follow up.
However, this study did not compare Ziihera with placebo and other cancer drugs.
“This approval reflects the MHRA’s commitment to ensuring patients can access safe and effective medicines where there is an unmet clinical need,” said Julian Beach, interim executive director of Healthcare Quality and Access at MHRA, Julian Beach.
He also said, “As with all approved medicines, we will continue to monitor the safety and effectiveness of zanidatamab as it is used more widely.”
However, zanidatamad also comes with a few side effects, and their details are mentioned on the package leaflet, the MHRA stated.
