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ENHERTU (AstraZeneca Pty Ltd)
Product name
ENHERTU
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
202 (255 working days)
Active ingredients
trastuzumab deruxtecan
Registration type
EOI
Indication
Unresectable or metastatic non-small cell lung cancer (NSCLC)
ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have activating HER2 (ERBB2) mutations and who have received prior platinum-based chemotherapy with or without immunotherapy. This indication was approved via the provisional approval pathway based on objective response rate. Continued approval of this indication depends on verification and description of benefit in a confirmatory trial.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration