NICE has today (19 December 2024)
issued final draft guidance recommending a new once-a-day tablet
that is set to benefit around 1,100 people with a type of
advanced breast cancer.
NICE's final draft guidance recommends
elacestrant (also called KORSERDU and made by Menarini Stemline)
for treating oestrogen receptor-positive, human epidermal growth
factor receptor 2-negative (HER2-), locally advanced or
metastatic breast cancer with an activating ESR1
mutation.
Elacestrant is recommended only if a
person's cancer has got worse after at least 12 months of
treatment with hormone therapy and a type of treatment designed
to interrupt the growth of cancer cells called a CDK 4 and 6
inhibitor.
Today's decision means NICE has
recommended 22 out of the 23 breast cancer treatments it has
assessed over the past 6 years.
Until now there have been no targeted
treatments available on the NHS for advanced breast cancer that
has an ESR1 mutation.
Elacestrant can also be used for
people whose cancer has a mutation in the PIK3CA gene as well as
an activating mutation in the ESR1
gene.
After initially not recommending
elacestrant because of uncertainties relating to the most
appropriate comparator and therefore uncertain evidence of how
long people have before their cancer gets worse compared with
standard care, NICE worked with the company to address this and
other issues highlighted by the independent appraisal
committee.
At its second meeting the committee
further explored the uncertainty and decided that a
severity weighting of 1.2 could
be applied to the subgroup of
people with an activating
ESR1-mutation.
By taking into account the severity of
the disease in this way it
meant elacestrant could be recommended as a cost-effective use of
NHS resources for people whose cancer has a mutation in the ESR1
gene as well as for people whose cancer has a mutation in both
the ESR1 and PIK3CA genes.
Helen Knight, director of
medicines evaluation at NICE,
said: “The committee
heard from the clinical and patient experts that people whose
advanced breast cancer has an ESR1 mutation tend to have worse
survival than people whose cancer doesn't have this
mutation. Disease progression
also tends to be faster for breast cancer with an ESR1
mutation.
“The committee understood that
patients living with advanced breast cancer prioritisetreatments
that extend life, support quality of life, and delay the need for
chemotherapy, while being safe and
tolerable.
“Elacestrant is a promising new
treatment with the potential to address these priorities.
We'retherefore pleased to be able to recommend it as a good use
of NHS resources and value for money for
taxpayers.”
Oestrogen receptor positive, HER2-
breast cancer is the most common type of breast cancer. Up to
half of the advanced or metastatic breast cancers treated with
hormone therapy develop mutations in the oestrogen receptor gene,
ESR1. The ESR1 gene makes oestrogen receptors, which receive
signals from oestrogen that tell the cancer to grow. This can
cause some hormone therapies to stop working and the cancer to
progress.
Elacestrant is a type of hormone
therapy called a selective oestrogen receptor antagonist and
degrader. It stops oestrogen-dependent cancer cells growing by
binding to and degrading oestrogen receptors, blocking
oestrogen's ability to bind to breast cancer
cells.
It is estimated around 1,100 people
will now be eligible for elacestrant on the NHS in
England.
