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Abemaciclib in combination with fulvestrant for advanced or metastatic breast cancer after prior endocrine therapy

Breast cancer, a cancer that develops from the tissues of the breast, is the most common cancer in the UK. There are many types of breast cancer and they are often grouped based on the presence or absence of some specific types of proteins (‘receptors’) in the cells of the patient. The most common type of breast cancer are those that are hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-). The advanced form of the HR+ and HER2- breast cancer occurs when the cancer has spread to other parts of the body such as the bones, brain and liver.

Abemaciclib is a new drug that is being developed for patients with the HR+/HER2- type of advanced breast cancer. The drug is being developed to be given in combination with fulvestrant, a drug that is already in use for the treatment of advanced breast cancer. Abemaciclib works differently from other drugs by targeting a very specific type of enzyme produced by cancer cells in patients with HR+/HER2- breast cancer. Abemaciclib is taken orally while fulvestrant is given by injection. If approved, the combination of both drugs will offer additional treatment options for patients with advanced HR+/HER2- breast cancer that have not responded well to other drugs.

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Abemaciclib (Breast)

Abemaciclib with an aromatase inhibitor is recommended as an option for treating locally advanced or metastatic, hormone receptor-positive, HER2-negative breast cancer as first endocrine-based therapy. (NICE TA563)

Abemaciclib with fulvestrant is recommended as an option for treating hormone receptor-positive, HER2- negative locally advanced or metastatic breast cancer in people who have had endocrine therapy only if exemestane plus everolimus would be the most appropriate alternative. (NICE TA725) Abemaciclib with endocrine therapy is recommended as an option for adjuvant treatment or hormone receptorpositive, HER2-negative, node-positive early breast cancer at high risk of recurrence See NHS BlueTeq form for eligibility.

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What is Abemaciclib and how does it work?

Abemaciclib is a type of oral, targeted cancer therapy called a “cyclin D kinase inhibitor.” Another name for this medicine is Verzenio. This medicine dissolves in your digestive system and is absorbed into your blood. Abemaciclib works to stop the cancer cell’s growth cycle and causes them to lose their ability to divide and spread. Abemaciclib is made in a laboratory.

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Abemaciclib As Initial Therapy for Advanced Breast Cancer

Approximately 70% of patients with metastatic breast cancer have hormone receptor (HR)–positive disease and are commonly treated with endocrinebased therapies that include an aromatase inhibitor (AI).1-4 Because resistance occurs in nearly all patients, attention has focused on identifying novel approaches to address endocrine resistance.

Cyclin-dependent kinases 4 and 6 (CDK 4 and CDK 6) in complex with D-type cyclin catalysts are critical regulators of cell cycle progression and have important implications in breast carcinogenesis and endocrine therapy resistance.11,12 Cyclin D1 is a major transcriptional target of the estrogen receptor. Following ligand binding of estrogen with its receptor, cyclin D1 is critically necessary for the transition from G1 to S phase in a CDK 4/cyclin D–dependent manner.13-16 Targeting CDK 4 and CDK 6 has been an effective means to attenuate the growth of HR-positive breast cancer.

[smiithwalkerr]

What is abemaciclib?

Abemaciclib is a targeted (biological) therapy. This group of drugs block the growth and spread of cancer. They target and interfere with processes in the cells that cause cancer to grow. Abemaciclib is the drug’s generic (non-branded) name. Its brand name is Verzenios. When used to treat breast cancer, abemaciclib is taken alongside hormone (endocrine) therapy.