Enzalutamide (Xtandi) for the treatment of advancing prostate cancer

Introduction

Enzalutamide (trade name: Xtandi) has been approved in Germany since June 2013 for the treatment of metastatic prostate cancer if conventional hormone blockers are no longer effective. Since September 2019, enzalutamide has also been approved for the treatment of non-metastatic prostate cancer if the tumor keeps growing despite the use of hormone blockers.

Blocking the production of testosterone in the testicles is one way to slow the growth of the prostate cancer. Cancer that continues to grow despite the use of hormone blockers is also referred to as "hormone-refractory" or "castration-resistant" prostate cancer.

If hormone-refractory prostate cancer has already spread (metastasized), complete recovery is no longer possible.

The drug enzalutamide aims to inhibit the growth of the cancer cells.

Application

Enzalutamide is taken once daily in the form of soft capsules or tablets at a dose of 160 mg. This is the equivalent of four soft capsules or coated tablets of 40 mg each, or two coated tablets of 80 mg.

If there are severe side effects, the treatment can be interrupted temporarily.

Other treatments

Enzalutamide for the treatment of metastatic prostate cancer 

Men with metastatic prostate cancer that no longer responds to conventional hormone blockers have several treatment options, depending on the stage of the disease and earlier treatments.

  • Even after hormone blockers stop working, many men have no or only mild symptoms for a while. During this phase, hormone blocker treatment can be continued as before or used together with non-steroidal anti-androgens (like flutamide or bicalutamide) or abiraterone.
  • More severe symptoms can be relieved with docetaxel chemotherapy. If the prostate cancer keeps growing during or after this treatment, patients usually receive supportive care adjusted to their individual needs and symptoms. Supportive care aims to relieve symptoms as much as possible and improve quality of life. This can include pain relief treatment, sometimes with very strong painkillers.

Enzalutamide for the treatment of non-metastatic prostate cancer

Watchful waiting is an option for men with non-metastatic prostate cancer if conventional hormone blockers are no longer effective enough. Treatment with hormone blockers is continued.

Assessment

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) last looked into whether enzalutamide has any advantages or disadvantages compared with the current standard treatments for advancing prostate cancer:

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 enzalutamide (Xtandi).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Enzalutamide – Benefit assessment according to § 35a Social Code Book V. Dossier assessment, Commission A13-33. December 2, 2013. (IQWiG reports; Volume 198).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Addendum to Commission A13-33 (enzalutamide). Dossier assessment; Commission A14-06. February 20, 2014. (IQWiG reports; Volume 204).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Enzalutamide (new therapeutic indication) – Benefit assessment according to § 35a Social Code Book V. Dossier assessment, Commission A14-48. March 30, 2015. (IQWiG reports; Volume 291).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Enzalutamide (prostate cancer) – Benefit assessment according to § 35a Social Code Book V; Dossier assessment; Commission A18-80. February 2, 2019. (IQWiG reports; Volume 726).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Enzalutamide (prostate cancer) – Addendum to Commission A18-80. Commission A19-34. April 25, 2019. (IQWiG reports; Volume 760).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Enzalutamide (prostate cancer) – Benefit assessment according to § 35a Social Code Book V; Dossier assessment; Commission A20-46. August 12, 2020. (IQWiG reports; Volume 955).

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 September 10, 2020
Next planned update: 2023

Authors/Publishers:

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

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