TAGRISSO (AstraZeneca Pty Ltd)
Product name
TAGRISSO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
86 (255 working days)
Active ingredients
osimertinib mesilate
Registration type
EOI
Indication
the treatment of patients with locally advanced, unresectable (stage III) NSCLC whose tumours have activating EGFR mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available