TAGRISSO (AstraZeneca Pty Ltd)
Product name
TAGRISSO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
119 working days (255)
Active ingredients
osimertinib mesilate
Registration type
EOI
Indication
TAGRISSO (tablets) is now also indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating epidermal growth factor receptor (EGFR) mutations.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available