10 August 2020

The Scottish Medicines Consortium (SMC) has today (10 August 2020) announced its decision to approve neratinib (Nerlynx) for routine NHS use in Scotland.

Neratinib (Pierre Fabre) is a tyrosine kinase inhibitor drug that offers an additional treatment option for certain patients with hormone positive, HER2 positive primary breast cancer after surgery and adjuvant treatment with trastuzumab – the current standard of care for these patients.

Neratinib works by attaching itself to the HER2 protein on cancer cells and blocking it to stop the cells growing and to prevent the cancer returning.

The marketing authorisation for neratinib requires that it is started within a year of completing trastuzumab. Patients are eligible for neratinib if they received trastuzumab alone after their surgery.

The ExteNET clinical trial demonstrated that 90.2% of patients taking neratinib after adjuvant trastuzumab were free of invasive disease five years later, compared to 87.7% of those in the placebo arm. The most common side effect from neratinib is diarrhoea, which can have a big impact on patients’ quality of life. However, it can usually be controlled with anti-diarrhoeal medication such as loperamide.

It is estimated that around 166 people a year in Scotland would be eligible for treatment with neratinib following adjuvant treatment with trastuzumab.

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, the research and care charity, said: 

It’s wonderful that some patients with HER2 positive breast cancer will now have access to an additional treatment option after trastuzumab to further reduce the risk of the disease coming back.

The fear of breast cancer returning or spreading to other parts of their body can cause women considerable anxiety and around a quarter of those with this type of early breast cancer experience a recurrence within ten years. Trastuzumab has been one of the greatest advances in treating breast cancer in recent decades and now, for some patients with HER2 positive breast cancer, being able to continue treatment with neratinib offers an important option to help further reduce the chance of the disease returning.

Continued advances in treating breast cancer, like neratinib, are absolutely vital to reaching our vision that by 2050, everyone who develops breast cancer will live – and live well.

It’s vital eligible patients have the information and support they need, and we therefore now need to see clinicians discuss this new treatment option and its risks and benefits with any eligible patients to ensure the right choice for each individual.