La FDA aprueba el medicamento Verzenio para tratar el cáncer de mama en estadio avanzado positivo para receptores de hormonas y negativo para HER2

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 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 seven 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:

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

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.

Editor’s Note: On Feb. 26, 2018, the FDA approved Verzenio to be used in combination with an aromatase inhibitor to treat post-menopausal women diagnosed with metastatic or advanced-stage hormone receptor-positive, HER2-negative breast cancer that has not been treated with hormonal therapy yet.

On Oct. 12, 2021, the FDA approved Verzenio in combination with either tamoxifen or an aromatase inhibitor after surgery to treat early-stage, hormone receptor-positive, HER2-negative node-positive breast cancer with a high risk of recurrence (the cancer coming back) and a Ki-67 score of 20% or higher. Node-positive means cancer cells have been found in one or more lymph nodes. Ki-67 is a protein in cells that increases as they prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. The more positive cells there are, the more quickly they are dividing and forming new cells.

On March 3, 2023, the FDA changed the way doctors decide if an early-stage, hormone receptor-positive, HER2-negative, node-positive breast cancer has a high risk of recurrence to see if Verzenio can treat it. The change removed the Ki-67 score requirement. So now doctors use node status, cancer size, and cancer grade to decide if the cancer has a high risk of recurrence