XTANDI (Astellas Pharma Australia Pty Ltd)
Product name
XTANDI
Date registered
Evaluation commenced
Decision date
Approval time
235 (255 working days)
Active ingredients
enzalutamide
Registration type
EOI
Indication
XTANDI is indicated for:
- the treatment of patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with biochemical recurrence at high-risk for metastasis (high-risk BCR).
- the treatment of patients with metastatic hormone-sensitive prostate cancer.
- the treatment of patients with non-metastatic castration-resistant prostate cancer (see PROSPER, section 5.1 Clinical trials).
- the treatment of patients with metastatic castration resistant prostate cancer following failure of androgen deprivation therapy in whom chemotherapy is not yet indicated.
- the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.