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.