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IMFINZI (AstraZeneca Pty Ltd)
Product name
IMFINZI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
211 (255 working days)
Active ingredients
durvalumab
Registration type
EOI
Indication
Malignant Pleural Mesothelioma (MPM)
IMFINZI in combination with pemetrexed and either cisplatin or carboplatin has provisional approval for the first-line treatment of patients with unresectable MPM with epithelioid histology. The decision to approve this indication has been made on the basis of two phase 2 single arm studies. Continued approval of this indication depends on verification and description of clinical benefit in a confirmatory trial.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.