OPDIVO (Bristol-Myers Squibb Australia Pty Ltd)
Product name
OPDIVO
Date registered
Evaluation commenced
Decision date
Approval time
227 (255 working days)
Active ingredients
nivolumab
Registration type
EOI
Indication
OPDIVO (concentrated solution for infusion), in combination with fluoropyrimidine and platinum-based combination chemotherapy, is now also indicated for the first-line treatment of patients with HER2 negative advanced or metastatic gastric or gastro-oesophageal junction or oesophageal adenocarcinoma.