FDA Expands Kisqali’s Uses

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Kisqali (chemical name: ribociclib; formerly called LEE011), in combination with an aromatase inhibitor, can now be used to treat premenopausal and perimenopausal women diagnosed with advanced-stage or metastatic, hormone-receptor-positive, HER2-negative breast cancer. Kisqali also can be used in combination with Faslodex (chemical name: fulvestrant) to treat the same type of breast cancer in postmenopausal women, according to an announcement from the Food and Drug Administration (FDA) on July 18, 2018.

Read the FDA press announcement.

Kisqali is now approved by the FDA to:

  • be used in combination with an aromatase inhibitor to treat advanced-stage or metastatic, hormone-receptor-positive, HER2-negative breast cancer that hasn’t been treated with hormonal therapy yet in premenopausal, perimenopausal, and postmenopausal women; premenopausal and perimenopausal women treated with Kisqali also should be treated with a luteinizing hormone-releasing hormone agonist, such as Zoladex (chemical name: goserelin), to suppress ovarian function
  • be used in combination with Faslodex (chemical name: fulvestrant) to treat advanced-stage or metastatic hormone-receptor-positive, HER2-negative breast cancer that hasn’t been treated with hormonal therapy yet, or has grown while being treated with a different hormonal therapy, in postmenopausal women

Kisqali is a cyclin-dependent kinase 4/6 inhibitor. Ibrance (chemical name: palbociclib) and Verzenio (abemaciclib) are other cyclin-dependent kinase 4/6 inhibitors used to treat breast cancer. A kinase is a type of protein in the body that helps control cell division. Kisqali works by stopping cancer cells from dividing and growing.

Kisqali is a pill taken by mouth.

Advanced-stage breast cancer is cancer that has spread to tissue near the breast, such as the chest wall, or breast cancer that has come back (recurred). Metastatic breast cancer is cancer that has spread to parts of the body away from the breast, such as the bones or liver. Metastatic breast cancer is also considered advanced-stage disease.

An aromatase inhibitor is a type of hormonal therapy medicine used to treat hormone-receptor-positive breast cancer. There are three aromatase inhibitors:

  • Arimidex (chemical name: anastrozole)
  • Aromasin (chemical name: exemestane)
  • Femara (chemical name: letrozole)

The aromatase inhibitors are also pills taken by mouth.

Faslodex is another type of hormonal therapy called an estrogen receptor downregulator. Faslodex is a liquid that is given once a month as an injection into a muscle.

Hormonal therapy medicines treat hormone-receptor-positive breast cancers in two ways:

  • by lowering the amount of the hormone estrogen in the body
  • by blocking the action of estrogen on breast cancer cells

Premenopausal or perimenopausal women prescribed Kisqali and an aromatase inhibitor also will be treated with a luteinizing hormone-releasing hormone agonist, such as Zoladex, to suppress ovarian function. Zoladex is given as an injection, usually in your doctor’s office, once a month for several months or every few months.

The FDA expanded the use of Kisqali for premenopausal and perimenopausal women based on results from the MONALEESA-7 study, which found that Kisqali in combination with an aromatase inhibitor and medicine to suppress ovarian function offered better progression-free survival than just an aromatase inhibitor and ovarian suppression medicine.

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

“Progression-free survival was nearly doubled [in the MONALEESA-7 study], so that was a very favorable result,” said Debu Tripathy, M.D., professor of medicine and chair of the department of breast medical oncology at the University of Texas MD Anderson Cancer Center, who led the study.

Listen to a podcast with Dr. Tripathy that explains the results of the MONALEESA-7 study.

The expanded use of Kisqali in combination with Faslodex was based on results from the MONALEESA-3 study, which found that Kisqali plus Faslodex offered better progression-free survival than Faslodex alone.

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

  • nausea
  • fatigue
  • diarrhea
  • hair loss
  • vomiting
  • headache
  • back pain
  • low white blood cell counts
  • constipation

Kisqali also may cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and can be fatal. Tell your doctor right away if you have a change in heartbeat, including a fast or irregular heartbeat, or if you feel dizzy or like you might faint.

Kisqali also may cause serious liver problems. Tell your doctor right away if you have any of the following signs of liver problems:

  • yellowing of the skin or the whites of the eyes
  • dark or brown urine
  • feeling very tired
  • loss of appetite
  • pain on the upper right side of the abdomen
  • bleeding or bruising more easily than normal

If you’re taking Kisqali, you should avoid pomegranates/pomegranate juice and grapefruit/grapefruit juice because they can interact with Kisqali.

If you’ve been diagnosed with advanced-stage, hormone-receptor-positive, HER2-negative breast cancer and are deciding on hormonal therapy treatments, you may want to ask your doctor if Kisqali makes sense for your unique situation.

When creating your treatment plan, you and your doctor will consider a number of factors, including:

  • the characteristics of the cancer
  • the risks and benefits of each treatment
  • your personal preferences
  • any affects on your quality of life

For more information, visit the Breastancer.org Kisqali pages.

To connect with others taking Kisqali, join the Breastcancer.org Discussion Board forum Stage IV and Metastatic Breast Cancer ONLY.


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