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Scottish Medicines Consortium (SMC) approves trastuzumab deruxtecan (Enhertu) for use on NHS in Scotland

Baroness Delyth Morgan, chief executive at Breast Cancer Now, said:

“This decision ushers in an exciting new era of treatment for people with HER2-low incurable secondary breast cancer in Scotland – providing for the first time an effective HER2-targeted treatment for this group of patients.[1][2] 


“Crucially, for eligible patients trastuzumab deruxtecan (Enhertu) can both slow the spread of the cancer and increase survival compared to chemotherapy, bringing people the life-changing hope of more time to live and do the things that matter most to them.  


“It’s vital this treatment now reaches all women who so desperately need it, as in England over two months after a provisional rejection by NICE there’s still no final decision.[3] With the process now paused, women will continue to endure an agonising wait to find out if they will get access to the treatment in time.[4] Daiichi Sankyo and NHS England must urgently agree a deal that makes this treatment available on the NHS. 


“People can speak to their clinical team about treatment options and can also call our free, confidential helpline on 0808 800 6000 to speak to our expert nurses for information and support.”  




Notes to editors 

[1] Trastuzumab deruxtecan has been assessed for treating HER2-low secondary (metastatic) or unresectable (cannot be removed by surgery) breast cancer after chemotherapy. It is the first treatment licensed for HER2-low breast cancer.  

[2] All invasive breast cancers are tested for HER2 (human epidermal grow factor receptor 2) levels. Some breast cancer cells have a higher than normal level of HER2 on their surface, which stimulates them to grow. There are various tests to measure HER2 levels. IHC (immunohistochemistry) is usually done first. It’s reported as a score of 0-3.   

Historically, patients usually find out whether their breast cancer is HER2 positive or HER2-negative. HER2 positive breast cancers can be treated with HER2-targeted therapies such as pertuzumab (Perjeta), trastuzumab deruxtecan (Enhertu), trastuzumab emtansine (Kadcyla). Around one in five invasive breast cancers are HER2 positive.   

Those whose breast cancer has lower levels of HER2 have always been considered HER2 negative and are not eligible for HER2 targeted treatments. Instead, they would be treated according to their hormone receptor status or whether they are triple negative. But now, within the HER2 population, there are breast cancers which have low levels of HER2 expression which are now being termed HER2-low rather than HER2-negative. It is estimated that around 50% of all breast cancers show low levels of HER2.  

[Historically, a score of 0 or 1+ means the breast cancer is HER2 negative. A score of 2+ is borderline and a score of 3+ means the breast cancer is HER2 positive. Breast cancers with borderline results should be retested using more specialised techniques. This is called an in-situ hybridization (ISH) test.  Now there is the additional classification of HER2-low. This is defined as a score of IHC 1+ or IHC 2+/ISH-] 

[3] NICE recommends drugs for use on the NHS in England. Wales and Northern Ireland normally follow NICE decisions. 

[4] Project information | Trastuzumab deruxtecan for treating HER2-low metastatic or unresectable breast cancer after chemotherapy [ID3935] | Guidance | NICE

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