OPDIVO (Bristol-Myers Squibb Australia Pty Ltd)
Product name
OPDIVO
Date registered
Evaluation commenced
Decision date
Approval time
187 working days (255)
Active ingredients
nivolumab
Registration type
EOI
Indication
OPDIVO, in combination with YERVOY (ipilimumab), is now also indicated for the treatment of patients with unresectable or metastatic melanoma. The approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. All analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.