The National Institute for Health and Care Excellence (NICE) has today (7 August 2019) announced its draft decision to provisionally approve neratinib for routine use on the NHS in England – with the recommendation now being consulted on before the drug is made available.

In new draft guidance, neratinib (Nerlynx, Pierre Fabre) has been recommended for use as an additional treatment option for certain patients with hormone positive, HER2 positive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. Patients with lymph node positive disease can take pertuzumab (Perjeta) alongside trastuzumab.

The marketing authorisation for neratinib requires that it is started within a year of completing trastuzumab. Patients would be eligible for neratinib if they received trastuzumab alone after their surgery or if they had treatment before surgery (neoadjuvant treatment) and had cancer cells remaining in tissue samples after surgery.

Neratinib is a type of drug known as a tyrosine kinase inhibitor. It attaches to the HER2 protein on cancer cells and blocks its action. As HER2 helps cancer cells grow and divide, blocking its action helps stop cancer cells growing and prevents cancer returning.

In a clinical trial (ExteNET), 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 – an improvement of 2.5 percentage points. The most common side effect from neratinib is diarrhoea, which can have a big impact on patients’ quality of life. However, it can normally be controlled with anti-diarrhoeal medication such as loperamide.

It is estimated that around 1,600 people would be eligible for treatment with neratinib following adjuvant treatment with trastuzumab.

The draft recommendation will be out for consultation until 28 August, with the NICE committee meeting in September to make a final decision on the drug.

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

It’s fantastic that hundreds of patients with early breast cancer could now have an additional treatment option to rely on after trastuzumab to further reduce the risk of their disease coming back.

The fear of breast cancer returning or spreading to other parts of their body can cause women considerable anxiety. Trastuzumab has been one of the greatest advances in treating breast cancer in recent decades, and being able to offer neratinib to further reduce the chances of the disease coming back could be really important, particularly for patients who aren’t eligible to take Perjeta.

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

We hope that the availability of neratinib will be confirmed following consultation and, if so, it’s vital that clinicians discuss the risks and benefits of the option with patients to help them make the treatment decision that is right for them.