OPDIVO (Bristol-Myers Squibb Australia Pty Ltd)
Product name
OPDIVO
Date registered
Evaluation commenced
Decision date
Approval time
211 working days (255)
Active ingredients
nivolumab
Registration type
EOI
Indication
OPDIVO (concentrated solution for IV infusion) is now also indicated for Hepatocellular Carcinoma. OPDIVO, as monotherapy, is indicated for the treatment of patients with hepatocellular carcinoma after prior sorafenib therapy. This indication is approved based on objective response rate and duration of response in a single arm study. An improvement in survival or disease-related symptoms has not been established.