NICE recommends zanidatamab for HER2-positive advanced biliary tract cancer, offering improved survival and quality of life for NHS patients in England.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending zanidatamab for routine use on the NHS in England for adults with HER2-positive advanced biliary tract cancer who have received at least one prior treatment.
Zanidatamab, also known as Ziihera and developed by Jazz Pharmaceuticals, is a targeted monoclonal antibody that binds to the HER2 protein on cancer cells, helping to slow or stop tumor growth.
Biliary tract cancers, including those affecting the bile ducts and gallbladder, are often diagnosed at an advanced stage and are associated with poor outcomes, with fewer than one-third of patients in England surviving beyond one year after diagnosis.
Treatment options for patients with disease progression have been limited, and around 65 patients annually are expected to be eligible for this therapy, which is administered as an intravenous infusion every two weeks.
Clinical trial data show that zanidatamab extends median overall survival to approximately 18 months, compared with around six months for standard chemotherapy such as FOLFOX.
The therapy may also reduce treatment burden, as it does not require a surgically implanted delivery device commonly associated with chemotherapy-related complications such as pain, fatigue, and nerve damage.
Helen Knight director of medicines evaluation at NICE stated that this is the first HER2-targeted treatment recommended for biliary tract cancer in England and noted that clinical experts and patients reported meaningful improvements in survival and quality of life.
Helen Morement CEO of AMMF The Cholangiocarcinoma Charity highlighted the absence of prior targeted options for this patient group and welcomed the availability of zanidatamab, while UK Public Health Minister Sharon Hodgson emphasized that the decision supports broader efforts to expand patient access to effective, innovative cancer treatments.
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About the Writer
Samiksha Vikram Jadhav is a B.Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She has a keen interest in healthcare advancements, clinical research, medical writing, and emerging therapies. Her work focuses on presenting developments in the pharmaceutical and healthcare sectors through clear and accurate scientific communication.
