1 Recommendations

1.1 Pembrolizumab is recommended, within its marketing authorisation, as an option with chemotherapy for neoadjuvant treatment and then continued alone as adjuvant treatment after surgery for adults with triple-negative:

  • early breast cancer at high risk of recurrence or

  • locally advanced breast cancer.

    It is recommended only if the company provides pembrolizumab according to the commercial arrangement.

Why the committee made these recommendations

Treatment for triple-negative early or locally advanced breast cancer is usually chemotherapy then surgery.

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

The cost-effectiveness estimates are likely to be within what NICE considers an acceptable use of NHS resources. So, pembrolizumab is recommended.