17 January 2022

The Scottish Medicines Consortium (SMC) has today announced its decision to recommend two new treatments – trastuzumab deruxtecan (Enhertu) and tucatinib (Tukysa) in combination with trastuzumab and capecitabine - for use on the NHS in Scotland.

The SMC’s approval of these treatments will offer new, innovative treatment options for patients with HER2 positive cancer that cannot be removed by surgery or secondary incurable breast cancer who have already had two or more other treatments specifically for this type of breast cancer.

Trastuzmab deruxtecan (also known as Enhertu) is a targeted (biological) treatment manufactured by Daiichi Sankyo.

It combines two drugs – a targeted drug like trastuzumab and a chemotherapy drug called deruxtecan. It works by the trastuzumab attaching itself to the HER2 proteins which can stop the cancer cells growing. When the trastuzumab attaches to the proteins, it delivers deruxtecan directly into the breast cancer cells to kill them.

Trastuzmab deruxtecan is recommended on an interim basis (interim acceptance route) subject to ongoing evaluation and reassessment once further evidence is available.

Tucatinib (also known as Tukysa) and manufactured by Seagen is a targeted therapy known as an oral tyrosine kinase inhibitor (TKI). It is taken in combination with trastuzumab and capecitabine.

Tucatinib helps control how cells grow and divide. It blocks a specific area of the HER2 gene in cancer cells, which stops the cells from growing and spreading.

Tucatinib in combination with trastuzumab and capecitabine is recommended for routine use on the NHS in Scotland.

Prior to this news, there were no HER2 targeted therapies available on the NHS for people with HER2 positive secondary breast cancer whose disease has progressed on or after 2 anti-HER2 therapies.

Responding, Baroness Delyth Morgan, Breast Cancer Now’s Chief Executive, said:

“That two new treatments for secondary breast cancer – trastuzumab deruxtecan (Enhertu)* and tucatinib (Tukysa) in combination with trastuzumab and capecitabine* – have been recommended for use in Scotland brings hope to patients who have progressed on previous treatments and urgently need new, clinically-effective targeted options.

“The SMC’s approval of these treatments marks a significant leap forward for certain women living with incurable HER2 positive secondary breast cancer; availability of the Tukysa combination will provide an important new option for certain people whose breast cancer has spread to the brain, who for too long have faced potentially shorter prognoses and poorer quality of life.

“For women who’ve progressed beyond two or more targeted treatments, access to Enhertu and the Tukysa combination could now give patients more time before their disease progresses and extend their lives, offering them precious extra time with loved ones.

“In England, Enhertu was approved for use on the Cancer Drugs Fund in 2021, but the appraisal for the Tukysa combination is ongoing. Drug company Seagen and NICE must continue to urgently work together to ensure the Tukysa combination can also be recommended for routine use on the NHS in England so that more patients can benefit from it as a treatment option, without enduring further delays.”

ENDS

Notes to editor

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

Trastuzmab deruxtecan will be recommended on an interim basis (interim acceptance route) subject to ongoing evaluation and reassessment once further evidence is available.

This interim acceptance route applies to medicines that:

Have been given a conditional marketing authorisation (licence) by the MHRA
Have received a MHRA early access to medicines scheme (EAMS) positive scientific opinion.
Have been included in the MHRA Innovative Licensing and Access Pathway (ILAP)

The interim acceptance option aims to align the SMC assessment with MHRA early regulatory access pathways and support early access to innovative medicines.

Tucatinib in combination with trastuzumab and capecitabine will be recommended for routine use on the NHS in Scotland.