OPDIVO (Bristol-Myers Squibb Australia Pty Ltd)
Product name
OPDIVO
Date registered
Evaluation commenced
Decision date
Approval time
186 working days (255)
Active ingredients
nivolumab
Registration type
EOI
Indication
OPDIVO, as monotherapy, is now also indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. The approval of this indication is based on objective response rate and duration of response in a single arm study.