NICE approves drug with potential to prevent breast cancer return

The National Institute for Health and Care Excellence published draft guidance recommending the drug neratinib as an extra treatment for a form of HER2-positive breast cancer.

“We are pleased to be able to recommend neratinib as a further treatment option”

Meindert Boysen

HER2-postitve breast cancer is a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells.

The draft guidance published today sets out how neratinib – also called Nerlynx – can be used in certain circumstances to treat early stage hormone positive HER2-positive breast cancer.

The drug is recommended as an extra treatment after surgery for those who have gone on to be treated with the drug trastuzumab – also known as Herceptin.

Treatment with neratinib should be started within a year of completing what it is known as “adjuvant” treatment with trastuzumab.

For people who had treatment before surgery – neoadjuvant treatment – to reduce tumour size the guidance states they should still have signs of cancer in tissue samples after surgery to be eligible for treatment with neratinib.

Nearly 50,000 women and 400 men are diagnosed with breast cancer each year in the UK and around one in five tumours will be HER2-positive.

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

The guidance from NICE comes on the back of evidence from a clinical trial, which found people treated with neratinib after trastuzumab have less risk of cancer returning than those given a placebo.

“Although there have been advances in the treatment of early stage HER2-positive breast cancer, around a quarter of people treated with trastuzumab following surgery will have a recurrence of their cancer,” said Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE.

“We are therefore pleased to be able to recommend neratinib as a further treatment option for people with this type of breast cancer, based on the benefits it provides in extending the time before the disease gets worse and on its important potential to reduce the risk of the cancer returning,” she added.

“It’s fantastic that hundreds of patients with early breast cancer could now have an additional treatment option”

Delyth Morgan

The most common side effect from the drug, which is taken as six 40mg tablets daily for a year, is diarrhoea. However, this can normally be controlled with medication.

Baroness Delyth Morgan, chief executive at Breast Cancer Care and Breast Cancer Now, said fear of breast cancer returning or spreading to other parts of their body was a major worry for those affected by the disease.

“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,” she said.

She hoped the availability of neratinib would be confirmed following consultation.

“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,” she added.

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