1 Recommendations

1.1 Abemaciclib with an aromatase inhibitor is recommended, within its marketing authorisation, as an option for treating locally advanced or metastatic, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer as first endocrine-based therapy in adults. Abemaciclib is recommended only if the company provides it according to the commercial arrangement.

Why the committee made these recommendations

Palbociclib or ribociclib, taken with an aromatase inhibitor, are usually the first treatments for locally advanced or metastatic, hormone receptor-positive, HER2-negative breast cancer. They are cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors, as is abemaciclib.

Clinical trial evidence shows that abemaciclib with an aromatase inhibitor increases how long people live without their disease getting worse, compared with an aromatase inhibitor alone. It is not known whether abemaciclib increases the length of time people live, because the final trial results are not available yet. Abemaciclib, palbociclib and ribociclib have different side effects, but they all appear to work as well as each other.

Taking into account the commercial arrangements for all the CDK 4/6 inhibitors, abemaciclib is a cost-effective use of NHS resources and it can be recommended.

  • National Institute for Health and Care Excellence (NICE)