Ribociclib (Kisqali) for the treatment of advanced breast cancer

Introduction

Ribociclib (trade name Kisqali) has been approved in Germany since August 2017 for the treatment of hormone-receptor-positive breast cancer in women, if the cancer has already spread to other parts of the body or is locally advanced. It is used as a part of hormone therapy in combination with an aromatase inhibitor or the anti-estrogen drug fulvestrant. Ribociclib can be used both in first-line hormone therapy as well as in a subsequent treatment if previous hormone therapy wasn't successful. In women before and during menopause, ribociclib is combined with a GnRH analogue.

Breast tumors are surgically removed, if possible. But sometimes the tumor has become too large or the cancer has spread to other parts of the body (metastasis) through the blood or lymphatic system. This is called advanced breast cancer.

One factor affecting the speed at which breast cancer cells grow and spread is whether they have receptors for such as estrogen or progesterone. If they do, the tumor is called hormone-receptor-positive (HR-positive) cancer. In these tumors, such as estrogen or progesterone accelerate the growth of cancer cells.

A certain protein on the surface of the cancer cells, called the HER2 receptor (human epidermal growth factor receptor 2), also reacts to growth signals and accelerates tumor growth. If there are a smaller number of these receptors on the cells of a breast tumor, it is called HER2-negative breast cancer. Ribociclib is approved only for the treatment of HER2-negative breast cancer in women.

Ribociclib inhibits cell division in the cancer cells, slowing down tumor growth.

Application

Ribociclib is available in the form of 200 mg tablets.

One treatment cycle lasts four weeks. In the first three weeks, the drug is taken once daily at the same time each day, ideally in the morning. The recommended daily dose is 600 mg (three 200 mg tablets). The next cycle starts after a one-week break. If there are severe side effects, the dose can be reduced or treatment can be interrupted. The treatment is stopped if the cancer continues to get worse or if severe side effects arise.

Ribociclib is combined with an aromatase inhibitor such as letrozole or with the anti-estrogen drug fulvestrant.

In women before and during menopause, ribociclib is also combined with a GnRH analogue.

Other treatments

The following standard treatments are available for advanced hormone-receptor-positive and HER2-negative breast cancer in women:

First-line hormone therapy:

  • After menopause aromatase inhibitors such as anastrozole or letrozole or the anti-estrogen drug fulvestrant can be used to reduce the amount of estrogen. If aromatase inhibitors aren't suitable, tamoxifen is an option.
  • Before and during menopause tamoxifen can be used. Medications are also used to block the production of .

Subsequent treatment if previous hormone therapy was unsuccessful:

  • After menopause the options include the drugs tamoxifen, anastrozole, fulvestrant, letrozole, exemestane, or a combination of everolimus and exemestane. The choice of drug will depend on previous treatments and the stage of the disease.
  • Before and during menopause various types of hormone therapy can be used to treat the cancer. The treatment is chosen depending on factors such as which other treatments have been tried before. It is individually adjusted by the doctor. Possible treatments include tamoxifen, letrozole, exemestane, megestrol acetate and medroxyprogesterone acetate.

Assessment

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of ribociclib in combination with an aromatase inhibitor or fulvestrant compared with the standard treatments for women with advanced hormone-receptor-positive and HER2-negative breast cancer.

The manufacturer did not provide any suitable data about the following:

  • The pros and cons of ribociclib as part of first-line hormone therapy in women with advanced breast cancer before and during menopause

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of ribociclib (Kisqali).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ribociclib (breast cancer) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A17-45. December 13, 2017. (IQWiG reports; Volume 567).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ribociclib (breast cancer) – Addendum to Commission A17-45. Commission A18-07. February 7, 2018. (IQWiG reports; Volume 595).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ribociclib (breast cancer) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A19-06. April 11, 2019. (IQWiG reports; Volume 752).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ribociclib (breast cancer; combination with fulvestrant) – Addendum to Commission A19-06; Commission A19-45. June 17, 2019. (IQWiG reports; Volume 783).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ribociclib (breast cancer; combination with an aromatase inhibitor) – Addendum to Commission A19-06; Commission A19-46. June 14, 2019. (IQWiG reports; Volume 781).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ribociclib (breast cancer; combination with aromatase inhibitors) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A20-21. May 28, 2020. (IQWiG reports; Volume 917).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ribociclib (breast cancer; combination with fulvestrant)  – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A20-22. May 28, 2020. (IQWiG reports; Volume 918).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Updated on July 4, 2019
Next planned update: 2022

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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