SCEMBLIX Novartis Pharmaceuticals Australia Pty Ltd
Product name
SCEMBLIX
Accepted date
Dec-2024
Active ingredients
asciminib hydrochloride
Proposed indication
SCEMBLIX is used to treat adults with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase." Ph+ CML is a cancer of the blood and bone marrow caused by the action of the Philadelphia chromosome, a shortened, abnormal version of chromosome 22. "Chronic phase" refers to the initial stage of the disease.
Application type
C (new indication)
Publication date
Dec-2024
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available.