The draft guidance recommends pembrolizumab (also called Keytruda and made by MSD) as an option with chemotherapy to try to reduce the size of the tumour before surgery (neoadjuvant treatment), and on its own as treatment after surgery (adjuvant treatment), for adults with triple-negative early breast cancer at high risk of recurrence or locally advanced breast cancer.

Today’s draft guidance means NICE has produced 3 positive pieces of guidance for treating triple-negative breast cancer in little over 4 months, and 17 for breast cancer as a whole since 2018. 

Triple-negative breast cancer can be more aggressive than other types of breast cancer and accounts for a quarter of all deaths from breast cancer despite accounting for only 1 in 5 cases.

Clinical trial evidence shows that adding pembrolizumab to chemotherapy before surgery, then continuing with pembrolizumab alone after surgery increases the chance that the cancer will disappear. It also increases the time before any cancer recurs. However, it is not clear if pembrolizumab increases how long people live.

It is estimated there are around 3,200 people in England with triple- negative breast cancer, of whom approximately 1,600 will be eligible for treatment with pembrolizumab under this draft guidance.

The committee heard that there are relatively few effective treatment options for people with triple-negative breast cancer and that adding pembrolizumab to standard care would be welcomed and is seen as an additional lifeline. This is particularly because triple-negative breast has an increased risk of recurrence compared with other forms of breast cancer. It is also associated with younger people, who may have young families.

Helen Knight, interim director of medicines evaluation at NICE, said: “Triple negative breast cancer has a relatively poor prognosis and there are few effective treatments compared with other types of the disease. Today’s draft guidance means that we have now recommended 3 new treatments for routine use in the NHS since June, helping to address this unmet need and giving hope of a longer and a better quality of life to thousands of people.”

NICE expects to publish its final guidance on pembrolizumab for treating early or locally advanced triple-negative breast cancer next month (December 2022).