A new targeted treatment for a rare and aggressive form of bile
duct cancer has today (Tuesday, 21 April) been recommended by
NICE for routine use on the NHS in England, giving people more
time with better quality of life.
NICE has recommended zanidatamab, also known as Ziihera and made
by Jazz Pharmaceuticals, in final draft guidance for adults with
HER2-positive advanced biliary tract cancer - a group of cancers
affecting parts of the body that store and transport bile,
including the bile ducts and gallbladder, who have already
received at least one treatment.
Biliary tract cancer is often diagnosed late, when it can no
longer be removed by surgery. Fewer than one in three people in
England survive for a year after diagnosis, and until now,
treatment options for patients whose cancer had progressed were
limited.
Around 65 people a year in England are expected to be eligible
for zanidatamab, which is given by an
intravenous infusion once every two weeks.
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.
Clinical trial data showed that people treated with zanidatamab
lived for an average of 18 months after taking the drug,
significantly longer than those receiving standard chemotherapy,
which was around six months.
Unlike the standard chemotherapy treatment for advanced biliary
tract cancer (known as FOLFOX), zanidatamab does not have to be
given through a surgically implanted device that can cause side
effects including pain, exhaustion, and nerve damage.
Helen Knight, director of medicines evaluation at NICE,
said: “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.
“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.
“We are determined to ensure NHS patients in England have access
to the most promising new treatments while providing value for
the taxpayer."
Helen Morement, CEO of AMMF – The Cholangiocarcinoma
Charity, said: “AMMF welcomes NICE's positive
recommendation of zanidatamab. Until now, people with
HER2-positive cholangiocarcinoma (bile duct cancer), gallbladder
cancer, or ampullary cancer whose disease had progressed on
first-line therapy had no targeted treatment options.
"During NICE's appraisal, we heard from patients and their
families about the positive difference zanidatamab provided for
them. We are therefore pleased that more people with advanced
HER2-positive disease will be able to access this life-extending
treatment through the NHS.”
NICE's independent appraisal committee agreed that a severity
weight of 1.7 was appropriate to reflect the significant impact
it has on how long people live with the condition given the lack
of treatment options.
The company has a commercial arrangement in place through a
confidential patient access scheme. This makes zanidatamab
available to the NHS with a discount.
Read the final draft guidance for zanidatamab for treating
HER2-positive advanced biliary tract cancer after 1 or more lines
of systemic treatment.
ENDS
Notes to editors
- Biliary tract cancer includes cholangiocarcinoma (bile duct
cancer), gallbladder cancer and ampullary cancer.
- Eligibility for the treatment is determined by testing for
high HER2 expression (IHC3 positive) at diagnosis.
- An embargoed copy of the final draft guidance document can be
downloaded here: ID6388 zanidatamab FDG v1.0
[noCON].pdf.
