NICE has today published draft guidance recommending trastuzumab
deruxtecan for use in the Cancer Drugs Fund (CDF) for treating a
type of breast cancer called HER2 positive breast cancer which
can’t be surgically removed or which has spread to other parts of
the body.
Today’s decision means it will be the first time trastuzumab
deruxtecan (also called Enhertu and jointly developed and
commercialised by Daiichi-Sankyo UK and AstraZeneca UK) has been
commissioned for use in any European country.
Up to 400 people will have immediate access to the treatment
while more data showing how much longer people who are taking it
live compared with people taking chemotherapy is collected.
Some breast cancer cells have higher levels of a protein called
HER2 on their surface, which stimulates them to grow. This is
known as HER2‑positive breast cancer and around 1 in 5 breast
cancers which can’t be surgically removed or which have spread to
other parts of the body are HER2‑positive.
Current treatment for HER2‑positive breast cancer which can’t be
surgically removed or which has spread to other parts of the body
includes anti‑HER2 therapies such as pertuzumab with trastuzumab
and docetaxel, or trastuzumab with paclitaxel. After 2 or more
anti‑HER2 therapies, standard care is chemotherapy (such as
capecitabine, vinorelbine or eribulin).
Trastuzumab deruxtecan is an anti‑HER2 therapy that would be used
after 2 or more anti‑HER2 therapies. It works by targeting the
changes in HER2 that help the cancer grow, divide and spread.
There is currently a lack of clinical trial data directly
comparing trastuzumab deruxtecan with chemotherapy. However, the
committee concluded that data from ongoing trials of trastuzumab
deruxtecan and from NHS practice would help address the
uncertainty about clinical effectiveness. Trastuzumab deruxtecan
is therefore recommended for use in the Cancer Drugs Fund.
Meindert Boysen, deputy chief executive and director of
the Centre for Health Technology Evaluation at NICE,
said: “Unfortunately there is no cure for breast cancer
that has spread to other parts of the body or that can’t be
removed surgically. The committee heard from patient experts who
explained that, because of its side effects, people want to avoid
having chemotherapies for as long as possible. They also
highlighted the need for treatments that can extend the length of
time before the disease gets worse while not having the same
negative impact on quality of life as chemotherapies.
“Trastuzumab deruxtecan is a promising new treatment that has the
potential to increase the length of time before the disease gets
worse and how long people live overall. We’re therefore pleased
that our work has allowed a deal to be struck between the company
and NHS England supporting access to trastuzumab deruxtecan as an
option in the CDF for people with this type of breast cancer.”
NICE expects to publish final guidance on trastuzumab deruxtecan
in May 2021. In the meantime interim funding for the drug will be
available.
