ALECENSA (Roche Products Pty Limited)
Product name
ALECENSA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
98 working days (255)
Active ingredients
alectinib hydrochloride
Registration type
EOI
Indication
ALECENSA is now also indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.