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ENHERTU (AstraZeneca Pty Ltd)
Product name
ENHERTU
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
252 (255 working days)
Active ingredients
trastuzumab deruxtecan
Registration type
EOI
Indication
Locally advanced or metastatic gastric cancer
ENHERTU is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2-based regimen. 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