The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 19 February 2026, approved zanidatamab
(Ziihera) for use in adults to treat biliary tract cancer (cancer
of the structures that store and transport bile) whose cancer
has high levels of a protein called HER2 and has
progressed after previous treatment.
Zanidatamab is used when the cancer cannot be removed by
surgery and has spread
to nearby tissues or other parts of the
body.
Zanidatamab is administered by an infusion drip
into a vein every two weeks.
A study in 80 patients with locally advanced or metastatic
biliary tract cancer that could not be removed by surgery found
that, among the 62 patients with high levels of HER2,
the cancer shrank or was no longer detectable in around 52% of
patients after an average follow-up of 34 months. The study
did not compare Ziihera with placebo or another cancer
medicine.
Beach, Interim Executive Director
of Healthcare Quality and Access at the MHRA,
said:
“Zanidatamab provides a new treatment option for adults with
advanced biliary tract cancer whose disease has high
levels of HER2 and has progressed following previous
treatment.
“This approval reflects the MHRA's commitment to ensuring
patients can access safe and effective medicines where there is
an unmet clinical need.
“As with all approved medicines, we will continue to monitor the
safety and effectiveness of zanidatamab as it is used more
widely.”
For the full list of side effects and restrictions with Ziihera,
see the package leaflet.
Notes to editors
