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IMFINZI (AstraZeneca Pty Ltd)
Product name
IMFINZI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
126 (255 working days)
Active ingredients
durvalumab
Registration type
EOI
Indication
IMFINZI as monotherapy is indicated for the treatment of adult patients with limited stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available