NICE has today (11 April 2025)
published final draft guidance recommending a new twice-a-day
tablet for treating a type of advanced breast
cancer.
Capivasertib (also called Truqap and
made by AstraZeneca) with fulvestrant is recommended as an option
for around 1,100 adults with hormone receptor (HR)-positive
HER2-negative breast cancer that has certain genetic mutations
and has spread.
Today's decision means capivasertib
with fulvestrant will be funded immediately through the Cancer
Drugs Fund.
NICE is looking at capivasertib with
fulvestrant for people whose cancer has come back or got worse
after treatment with a type of drug called a CKD 4 and 6
inhibitor and an aromatase inhibitor, a type of hormone
therapy.
The independent appraisal committee
was able to apply a severity modifier of 1.2. This allows
medicines that are used to treat conditions classed as high or
medium severity to have a higher threshold at which they can be
considered cost-effective.
Given as a twice-a-day tablet,
capivasertib is a targeted treatment called a kinase inhibitor.
It works by blocking the action of an abnormal protein that
signals cancer cells to multiply. This helps slow or stop the
spread of cancer cells. Results from a clinical trial showed that
capivasertib plus fulvestrant increased the time before the
cancer got worse by around 4.2 months compared with placebo plus
fulvestrant.
Although capivasertib plus fulvestrant
has not been directly compared in a clinical trial with
NICE-recommended alpelisib plus fulvestrant or everolimus plus
exemestane, indirect comparisons suggest that it is likely to
work as well as these.
Helen Knight, director of
medicines evaluation at NICE, said:
“The patient experts described the
devastating impact that being diagnosed with advanced breast
cancer has on people's lives. They also highlighted the value of
having a well-tolerated treatment that delays their cancer
getting worse and targets AKT1 or PTEN gene alterations, noting
that there are currently none
available.
“People with advanced breast cancer
would value treatments like capivasertib that can be given when
limited options exist and because it may delay the need for
chemotherapy and its associated
side-effects.
“We are therefore pleased the company
has worked with us so that we are able to recommend
this promising new treatment
as a good use of NHS resources and value for money for
taxpayers.”
In 2020 in England, 40,192 people were
diagnosed with breast cancer, approximately 14.8% of who had
advanced stage disease when they were
diagnosed.
Hormone receptor (HR)-positive
HER2-negative advanced breast cancer is incurable and the aim of
treatment is to delay it getting worse and extend how long people
live. If the cancer has alterations in the PIK3CA, AKT1 or PTEN
genes, outcomes appear to be worse. Around 40% to 50% of people
with HR-positive HER2-negative breast cancer have PI3K and AKT
pathway alterations, of which over 75% are in the PIK3CA
gene.
Today's recommendation means NICE has
approved 24 out of the 25 breast cancer treatments it has
assessed over the past 7 years.
