Abemaciclib (EU: Verzenios, U.S.: Verzenio) and fulvestrant for the treatment of advanced breast cancer

Abemaciclib is available in the form of tablets, in three different doses: 50, 100 and 150 mg. The recommended dose is 150 mg twice a day.

The dose depends on how well the patient tolerates the drug, as well as on the side effects, and can be adjusted individually.

For women with advanced hormone-receptor-positive and HER2-negative breast cancer, the following standard treatments are available:

First-line antihormonal treatment:

• Women who have already gone through menopause can use aromatase inhibitors such as anastrozole or letrozole or the anti-estrogen drug fulvestrant, which block hormone production. If these medications can’t be used, tamoxifen is an option.
• Women who haven’t yet gone through menopause, or who are still going through menopause, can use tamoxifen. Menopause is then also induced with medication.

Subsequent treatment if previous antihormonal treatment was unsuccessful:

• For women who have already gone through menopause, the options include the drugs tamoxifen, anastrozole, fulvestrant, letrozole, exemestane, or everolimus in combination with exemestane. The choice of drug will depend on previous treatments and the stage of the disease.
• Women who haven’t yet gone through menopause, or who are still going through menopause, can have a number of additional antihormonal treatments to fight the cancer. This is chosen depending on factors such as which treatments have been tried before. The treatment is individually modified by the doctor.

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of abemaciclib in combination with fulvestrant compared with the standard treatments for women with advanced hormone-receptor-positive breast cancer. They did two separate assessments: one for treatment with abemaciclib as part of first-line treatment, and one for abemaciclib when used in subsequent treatment.

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of abemaciclib (EU: Verzenios, U.S.: Verzenio).