IMFINZI (AstraZeneca Pty Ltd)
Product name
IMFINZI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
183 (255 working days)
Active ingredients
durvalumab
Registration type
EOI
Indication
Biliary tract cancer (BTC)
IMFINZI in combination with gemcitabine and cisplatin is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (BTC).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.