NICE draft guidance recommends tucatinib for advanced breast cancer

Around 400 people with advanced breast cancer are set to benefit from a new treatment after the UK’s National Institute for Health and Care Excellence (NICE) published final draft guidance which recommends tucatinib as an option for treating HER2-positive breast cancer that has spread in people who have already tried 2 or more anti-HER2 treatments.

Taken as two 150 mg tablets twice daily together with anti-cancer medicines trastuzumab and capecitabine, tucatinib works by blocking a specific area of the HER2 gene in cancer cells, which stops the cells from growing and spreading.

Following the previous draft guidance which did not recommend the tucatinib combination, the company provided further analyses to demonstrate its benefit, especially for people with brain metastases. The company also provided a further discount on the price that the NHS would pay for tucatinib.

Helen Knight, programme director in 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 also a lack of additional anti‑HER2 treatments which can postpone the need for chemotherapy, especially for people whose cancer has spread to their brain 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. And because tucatinib is able to cross an intact blood-brain barrier it offers people whose cancer has spread to their brain real hope of extending their lives and improving their quality of life. We are therefore pleased to be able to recommend it for routine use in the NHS.”

There are many different types of breast cancer. A tumour is referred to as ‘HER2-positive’ when cancer cells overexpress a protein called HER2 (human epidermal growth factor receptor 2). This stimulates the cancer cells to grow and spread. HER2-positive tumours are typically more aggressive than other types of breast cancer. An estimated 47,000 people are diagnosed with breast cancer each year in England and around 1 in 5 breast cancers are HER2 positive.

Current treatment for HER2‑positive breast 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 2 or more anti‑HER2 treatments is chemotherapy (such as capecitabine, vinorelbine or eribulin).

NICE expects to issue final guidance on tucatinib in combination with trastuzumab and capecitabine this month (March).

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