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 2018, 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 keep prostate cancer from progressing. Cancer that continues to grow despite the use of these 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.
Enzalutamide is taken once a day in the form of soft capsules or tablets at a dose of 160 mg. This is equivalent to four soft capsules containing 40 mg each or two tablets containing 80 mg of enzalutamide each.
If there are severe side effects, the treatment can be interrupted temporarily.
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 therapies.
- 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.
In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether enzalutamide has any advantages or disadvantages compared with the current standard treatments for advancing prostate cancer:
- Enzalutamide for the treatment of metastatic prostate cancer if hormone blockers are no longer effective
- Enzalutamide for the treatment of metastatic prostate cancer during and after docetaxel chemotherapy
- Enzalutamide for the treatment of non-metastatic prostate cancer
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 02, 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 carcinoma) – Benefit assessment according to § 35a Social Code Book V; Dossier assessment, Commission A18-80. February 26, 2019. (IQWiG reports, Volume 726)
IQWiG health information is written with the aim of helping
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