Basic Information
Enzalutamide Viatris
Regulatory Information
EMEA/H/C/006299
August 22, 2024
June 27, 2024
2
October 9, 2024
Company Information
Ireland
Damastown Industrial Park Dublin 15
VIATRIS PHARMA LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Enzalutamide Viatris is indicated: • 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); • in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1); • for 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); • for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Overview Summary
Enzalutamide Viatris is a cancer medicine used to treat men with prostate cancer. It can be used: - 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 (depending on a hormone, such as testosterone, to grow); - for metastatic cancer that is castration-resistant (worsens despite treatment to lower production of testosterone or after surgical removal of the testes) when either: - treatment with docetaxel (another cancer medicine) has not worked or no longer works, or - 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); - for castration-resistant prostate cancer that is not metastatic but is at high risk of doing so; - 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). Enzalutamide Viatris contains the active substance enzalutamide and is a ‘generic medicine’. This means that Enzalutamide Viatris contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Enzalutamide Viatris is Xtandi. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf).