Giving hope to those affected
by secondary breast cancer

Research. Support. Education.

SMC Approval for trastuzumab deruxtecan (Enhertu®)

12th April 2023 by Alexander Kolliari-Turner

SMC Approval

The SMC approves trastuzumab deruxtecan (Enhertu®) for HER2+ secondary breast cancer patients in Scotland.

The Scottish Medicines Consortium (SMC) has announced that trastuzumab deruxtecan (Enhertu®) has been approved for usage within NHSScotland for metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2-based regimens. 

The National Institute for Health and Care Excellence (NICE) approved trastuzumab deruxtecan for this same patient cohort in NHS England & Wales in December 2022

The SMC has already accepted trastuzumab deruxtecan as a treatment for metastatic HER2-positive breast cancer patients who have received two or more prior anti-HER2-based regimens. With this new decision trastuzumab deruxtecan will now become available to this patient demographic as an earlier treatment option. 

Current standard of care for secondary HER2-positive breast cancer patients is a combination of taxane (a type of chemotherapy) with trastuzumab, which can be administered alongside the anti-HER2 medicine, pertuzumab. On progression of disease, in the second-line setting, trastuzumab emtansine is used. This SMC decision means that trastuzumab deruxtecan will now be offered instead of trastuzumab emtansine in the second line setting.   

A phase III clinical trial (known as DESTINY-Breast03) showed that secondary HER2-positive breast cancer patients who were treated with trastuzumab deruxtecan instead of trastuzumab emtansine, as a second line of treatment, had a significantly longer period of time until further disease progression and a greater overall chance of survival. 

Make 2nds Count welcomes this decision by the SMC. Dr Sarah Thomas, Research Manager said: "This is very welcome news for patients living with HER2-positive secondary breast cancer in Scotland. This treatment offers patients not just precious time, but vitally time that is disease progression free. The decision to approve this treatment brings Scotland in line with the rest of the UK in terms of access to Enhertu on the NHS."