IMFINZI (AstraZeneca Pty Ltd)
Product name
IMFINZI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
113 (255 working days)
Active ingredients
durvalumab
Registration type
EOI
Indication
Gastric and gastroesophageal junction (GOJ) cancer (GC/GOJC)
IMFINZI in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, is indicated for the treatment of adults with resectable gastric or gastroesophageal junction adenocarcinoma.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available