NICE has published draft guidance for public consultation which does not recommend tucatinib, in combination with trastuzumab and capecitabine, for some types of breast cancer.

Tucatinib is licenced for treating HER2-positive (human epidermal growth factor receptor 2) locally advanced or metastatic breast cancer in people who have received at least two prior anti-HER2 treatment regimens. NICE concludes that, based on comparisons of the tucatinib combination with standard care such as chemotherapy, people taking the tucatinib combination have long before their disease progresses, and they live longer overall. However, it is still uncertain how much longer patients live.

Approximately 47,000 people are diagnosed with breast cancer each year in England, and around one in five breast cancers are HER2 positive. A tumour becomes ‘HER2-positive’ when cancer cells overexpress a protein called HER2, which stimulates the cancer cells to grow and spread. These tumours are typically more aggressive than other types of breast cancer.

Existing treatment for this type of cancer, which has spread to other parts of the body, includes anti-HER2 treatments such as pertuzumab with trastuzumab and docetaxel, or trastuzumab with paclitaxel. Standard care after two or more anti-HER2 treatments is chemotherapy (such as capecitabine, vinorelbine, or eribulin).

Tucatinib, a tyrosine kinase inhibitor, works by blocking a specific area of the HER2 gene in cancer cells, which stops the cells from spreading.

Meindert Boysen, deputy chief executive and director of the NICE Centre for Health Technology Evaluation, said: “Unfortunately there is no cure for breast cancer that has spread to other parts of the body. There is a lack of additional anti?HER2 treatments, which can postpone the need for chemotherapy, especially for people whose cancer has spread to their brains because their treatment options are even more limited.

“Tucatinib is a promising, innovative new treatment that has the potential to increase the length of time before the disease gets worse and how long people live overall. We will continue to work with the company as they seek to address the issues highlighted in today’s draft recommendations.”