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NICE approves life-extending drug for rare bile duct cancer patients

The recommendation is an important step in the treatment of bile duct cancer, as it is often diagnosed late, when surgeries are impossible

NICE approves drug bile duct cancer

A patient receiving intravenous infusion

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Key Summary

  • National Institute for Health and Care Excellence has recommended Zanidatamab for adults with HER2-positive advanced biliary tract cancer after prior treatment
  • The drug targets HER2 on cancer cells and can extend survival by around 18 months, offering a new option where treatments are limited
  • Around 65 patients a year in England could benefit from this less invasive, life-extending therapy

The National Institute of Health and Care Excellence (NICE) has recommended zanidatamad or Ziihera, manufactured by Jazz Pharmaceuticals, for adults with HER2-positive advanced biliary tract cancer, and have received at least one treatment.


Biliary tract cancer affects parts of the body that store and transport bile, including the bile ducts and gallbladder.

The recommendation is an important step in the treatment of bile duct cancer, as it is often diagnosed late, when surgeries are impossible.

Less than one in three people in England survive for year post-diagnosis, with limited treatment options.

However, Ziihera is an alternative treatment for the patients who found other treatments unsuccessful.

It works by recognising and attaching to a protein called HER2 found on the surface of cancer cells and slows or stops the cancer cells from growing.

It is recommended after a clinical trial which proved that zanidatamab improved their lifespan by an average of 18 months, over the patients receiving standard chemotherapy once in every six months.

It is also a convenient form of treatment as it does not require any surgically implanted devices which could cause pain, exhaustion and even nerve damage to the patient, unlike the standard chemotherapy for biliary tract cancer called FOLFOX.

Currently, nearly 65 people are eligible for this intravenous infusion once every two weeks in a year.

The drug identifies the cancer cells, attaches to the HER2 on the cells and stops the cells from growing further.

“I am pleased we have been able to recommend this effective new treatment option, the first HER2-targeted drug NICE has recommended for people with biliary tract cancer in England,” commented director of medicines evaluation at NICE, Helen Knight.

She said, “Patients and clinical experts involved in the appraisal told us how this treatment would make a huge difference by extending people’s lives and improving their quality of life - something that was not always possible with chemotherapy.”

“Through the National Cancer Plan, this government is committed to making sure NHS patients get access to the best new treatments, and today’s recommendation delivers exactly that,” added the minister for public health, Sharon Hodgson MP.