YONSA MPRED (Sun Pharma ANZ Pty Ltd)
Product name
YONSA MPRED
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
206 (255 working days)
Active ingredients
abiraterone acetate; methylprednisolone
Registration type
NCE/NBE
Indication
New Combination
YONSA MPRED (tablet) is indicated for the treatment of patients with:
- newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT), or
- 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.