1 Recommendations

1.1 Abemaciclib with endocrine therapy is recommended, within its marketing authorisation, as an option for adjuvant treatment of hormone receptor-positive, HER2-negative, node‑positive early breast cancer in adults whose disease is at high risk of recurrence, defined by the following clinical and pathological features:

  • at least 4 positive axillary lymph nodes, or

  • 1 to 3 positive axillary lymph nodes, and at least one of the following criteria:

    • grade 3 disease (defined as at least 8 points on the modified Bloom–Richardson grading system or equivalent), or

    • primary tumour size of at least 5 cm.

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

Why the committee made these recommendations

Adjuvant treatment aims to reduce the risk of cancer returning after surgery. Chemotherapy followed by endocrine therapy is standard care for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence. Abemaciclib plus endocrine therapy is another adjuvant treatment option.

Clinical trial evidence shows that adjuvant treatment with abemaciclib plus endocrine therapy increases how long people are free of disease compared with endocrine therapy alone. This is for people whose condition is at high risk of recurrence because the cancer has spread into:

  • at least 4 axillary (armpit) lymph nodes, or

  • 1 to 3 axillary lymph nodes, and there is either grade 3 disease or the primary tumour is at least 5 cm.

It is uncertain how long the benefit of abemaciclib with endocrine therapy lasts because data is still being collected.

The cost-effectiveness estimates are also uncertain, but the most likely estimates are within the range NICE considers an acceptable use of NHS resources. Therefore, abemaciclib is recommended.

  • National Institute for Health and Care Excellence (NICE)