25 February 2022

The National Institute for Health and Care Excellence (NICE) has today (Friday 25 February 2022) announced its decision to recommend breast cancer treatment tucatinib with trastuzumab and capecitabine for routine use on the NHS in England for treating HER2 positive, locally advanced or secondary breast cancer after at least two prior anti-HER2 treatment regimens.

Tucatinib (also known as Tukysa), manufactured by Seagen, is a targeted therapy known as an oral tyrosine kinase inhibitor (TKI) and works by blocking a specific area of the HER2 gene in cancer cells, which stops the cells from growing and spreading.

The latest data from the HER2CLIMB clinical trial presented at ASCO 2021 showed that tucatinib with trastuzumab and capecitabine can extend the time before a patient's condition progresses (progression-free survival) by 2.7 months on average, compared to trastuzumab with capecitabine. The tucatinib combination also improved overall survival, giving patients an additional 5.5 months on average, compared with trastuzumab and capecitabine. The improvement in progression-free and overall survival was observed in people with and without brain metastases.

This treatment combination was provisionally rejected by NICE in October 2021 as it was not considered cost-effective.

It is estimated that around 400 people each year in England will now be eligible for this treatment.

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:

“Today’s approval of new breast cancer drug tucatinib with trastuzumab and capecitabine brings hope to hundreds of eligible patients* with HER2 positive, locally advanced or secondary breast cancer and the chance of precious extra months before their disease progresses, and even an extension to their lives – giving women more quality time to do what matters most to them.

“Following its worrying provisional rejection of this promising treatment last October, NICE’s positive final decision now guarantees its routine use on the NHS. This is a huge step forward, particularly for eligible patients whose breast cancer has spread to the brain and who, until now, faced the heart-breaking reality of limited treatment options and potentially shorter prognoses and poorer quality of life.

“We understand that NHS England will direct clinicians to give trastuzumab either intravenously or by injection (subcutaneously) as part of this treatment combination.* The injection is a quicker and kinder form of the treatment for patients – and with patients spending less time in hospital, this approach could also free up precious time for healthcare professionals, reducing the burden on our severely strained NHS.

“We encourage women to discuss their breast cancer treatment options with their healthcare team, and they can also speak to our expert nurses by calling our free Helpline on 0808 800 6000.”


Notes to Editor

*After two or more other treatments specifically for HER2 positive breast cancer, i.e. anti-HER2 treatments

* While the final NICE guidance states the trastuzumab part of combination should be given intravenously, due to cost, we understand NHS England will be directing clinicians to use either the intravenous or subcutaneous (injection) trastuzumab administration as part of this treatment combination