FDA Approves Verzenio (Abemaciclib) for Certain Advanced Breast Cancers

Written By:Stacy Simon

The US Food and Drug Administration (FDA) has approved Verzenio (abemaciclib) for women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that is in an advanced stage and has gotten worse after hormone therapy treatment.

In HR-positive breast cancers, the hormones estrogen and/or progesterone attach to receptors on cancer cells and help them grow. Hormone therapy drugs can be used to interfere with this process and keep the cancer from growing and spreading. HER2 is a protein found on some breast cancer cells that help them grow. Other types of drugs are used to target HER2-positive breast cancer.

Verzenio is a type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. It’s the third of this type of drug to be approved for breast cancer. The others are Ibrance (palbociclib) and Kisqali (ribociclib). These drugs block CDK proteins in the cell, especially CDK4 and CDK6. Blocking these proteins in HR-positive breast cancer cells helps stop the cells from dividing and can slow cancer growth.

Verzenio is approved to be given in combination with the hormone therapy drug Faslodex (fulvestrant) in women whose cancer has grown while on hormone therapy. But the drug can also be given on its own in women who have previously been treated with hormone therapy and chemotherapy.

The FDA based its approval on the results of 2 clinical trials.

One trial involved 669 women with HR-positive, HER2-negative, advanced breast cancer that had grown after they received hormone therapy, and who did not receive chemotherapy after the cancer spread. The study measured progression-free survival, which is the amount of time after treatment that tumors did not grow. The women who received Verzenio and Faslodex had an average progression-free survival of 16.4 months compared to an average of 9.3 months for women who received Faslodex without Verzenio.

The other trial studied Verzenio as a stand-alone treatment. In this trial, 132 women with HR-positive, HER2-negative breast cancer all received Verzenio. These women had previously received hormone therapy and chemotherapy after their cancer spread. The study measured objective response rate, which is the percentage of women whose tumors got smaller or disappeared after treatment. In the study, the objective response rate was 19.7% and the response lasted for an average of 8.6 months.

Common side effects of Verzenio include diarrhea, low blood counts, nausea and vomiting, abdominal pain, infection, fatigue, decreased appetite, and headache. Serious infection, diarrhea, elevated liver blood tests, and blood clots are also possible. Women who are pregnant should not take Verzenio.

The FDA used 2 programs – priority review and breakthrough therapy – to evaluate Verzenio. These programs are designed to speed up the availability of drugs to treat serious diseases.

Verzenio is marketed by Eli Lilly and Company.

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