Enzalutamide
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Prostate cancer6 | |||
None | Monotherapy | 1L metastatic | Castration-resistant only; Failure of androgen deprivation therapy; Asymptomatic or mildly symptomatic; chemotherapy is not yet clinically indicated |
None | Monotherapy | 2L metastatic | Castration-resistant only; Progressed on or after docetaxel therapy |
None | + androgen deprivation therapy | Any line locally adv. | Hormone-sensitive only; High-risk biochemical recurrent (BCR); unsuitable for salvage-radiotherapy |
None | + androgen deprivation therapy | Any line metastatic | Hormone-sensitive only |
None | Monotherapy | Any line locally adv. | Hormone-sensitive only; High-risk biochemical recurrent (BCR); unsuitable for salvage-radiotherapy |
None | Monotherapy | Any line locally adv. | Castration-resistant only; High-risk |
Full text of section 4.1 (therapeutic indications)
Xtandi 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.
Label history
34 changes to the Xtandi label since 2014, 4 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes