FDA Approves Verzenio to Treat Advanced-Stage, Hormone-Receptor-Positive, HER2-Negative Breast Cancer

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The targeted therapy Verzenio (chemical name: abemaciclib) was approved by the U.S. Food and Drug Administration (FDA) on Sept. 28, 2017 to be used in combination with Faslodex (chemical name: fulvestrant) to treat women diagnosed with hormone-receptor-positive, HER2-negative, metastatic or advanced-stage breast cancer if the cancer progressed after hormonal therapy treatment. Verzenio also was approved to be used alone to treat women and men diagnosed with hormone-receptor-positive, HER2-negative, metastatic or advanced-stage breast cancer if the cancer progressed after hormonal therapy treatment and chemotherapy if the cancer is metastatic.

Like Ibrance (chemical name: palbociclib) and Kisqali (chemical name: ribociclib), Verzenio is a cyclin-dependent 4/6 kinase inhibitor. A kinase is a type of protein in the body that helps control cell division. Verzenio works by stopping cancer cells from dividing and growing. Verzenio is a pill taken by mouth.

The recommended starting doses of Verzenio are 150 mg twice per day in combination with Faslodex or 200 mg twice per day used alone.

Advanced-stage cancer is breast cancer that has spread beyond the breast to nearby tissues, such as the skin or the chest wall. Metastatic breast cancer is breast cancer that has spread to a part of the body away from the breast, such as the bones or liver. Metastatic breast cancer is advanced-stage breast cancer.

The approval of Verzenio in combination with Faslodex is based on results from the MONARCH 2 study. The study found that women diagnosed with metastatic, hormone-receptor-positive, HER2-negative breast cancer that had grown while being treated with hormonal therapy other than Faslodex had 7 months longer progression-free survival if they were treated with Verzenio and Faslodex compared to women treated with Faslodex alone.

Progression-free survival is how long the women lived without the cancer growing.

The approval of Verzenio to be used alone was based on results from the MONARCH 1 study. The study looked at 132 people diagnosed with hormone-receptor-positive, HER2-negative breast cancer that had progressed after treatment with hormonal therapy and chemotherapy after the cancer metastasized. In the study, 19.7% of people taking Verzenio had complete or partial shrinkage of the cancer for an average of 8.6 months.

Like almost all cancer medicines, Verzenio can cause side effects, some of them severe. The most common severe side effects of Verzenio are:

  • diarrhea
  • anemia (low red blood cell count)
  • neutropenia and leukopenia (low white blood cell counts)
  • infection

Overall, the most common side effects of any severity that happened in more than 20% of people treated with Verzenio were:

  • diarrhea
  • nausea
  • neutropenia
  • abdominal pain
  • infections
  • fatigue
  • anemia
  • leukopenia
  • decreased appetite
  • vomiting
  • headache

If you’ve been diagnosed with advanced-stage or metastatic, hormone-receptor-positive, HER2-negative breast cancer that has grown while being treated with hormonal therapy, you may want to talk to your doctor about Verzenio and ask if it makes sense for your unique situation.


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