TAGRISSO (AstraZeneca Pty Ltd)
Product name
TAGRISSO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
141 (255 working days)
Active ingredients
osimertinib mesilate
Registration type
EOI
Indication
TAGRISSO (tablet) is now also indicated as adjuvant therapy after tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have activating epidermal growth factor receptor (EGFR) mutations, as detected by a validated test.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available