<p>Xtandi is a cancer medicine used to treat men with prostate cancer. It can be used:</p><ul><li>together with hormone therapy (treatment to lower production of testosterone) when the cancer is metastatic (has spread to other parts of the body) and is hormone-sensitive (a cancer that depends on a hormone, such as testosterone, to grow);</li><li>for metastatic cancer that is castration-resistant (worsens despite treatment to lower production of testosterone or after surgical removal of the testes) and when either:<ul><li>treatment with docetaxel (a cancer medicine) has not worked or no longer works, or</li><li>hormone therapy has not worked, and the patient has either no symptoms or mild symptoms and does not yet require chemotherapy (another type of cancer treatment);</li></ul></li><li>for castration-resistant prostate cancer that is not metastatic (has not yet spread) but is at high risk of doing so;</li><li>on its own or together with hormone therapy for hormone-sensitive prostate cancer that is not metastatic if there are rapidly rising levels of prostate-specific antigen (PSA; a protein made by the prostate gland), indicating that the cancer may have returned, in men who cannot receive salvage radiotherapy (radiation treatment given after the cancer has not responded to other treatments).</li></ul><p>The medicine contains the active substance enzalutamide.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p style="margin-left:5.4pt;">Xtandi is indicated for:</p><ul><li>as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1).</li><li>the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).</li><li>the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).</li><li>the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).</li><li>the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.</li></ul></div>
Therapeutic Area (MeSH)
ATC Code
L02BB04
ATC Item
N/A
Pharmacotherapeutic Group
Endocrine therapy
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| enzalutamide | N/A | enzalutamide |
EMA Name
Xtandi
Medicine Name
Xtandi
Aliases
N/ANo risk management plan link.