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(Actor Pharmaceuticals Pty Ltd)
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
151 (255 working days)
Active ingredients
abiraterone acetate, prednisolone
Registration type
New combination
Indication
ANDRIGA-5 is indicated for the treatment of:
- newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
ANDRIGA-10 is indicated for the treatment of:
- patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) or
- patients with mCRPC who have received prior chemotherapy containing a taxane