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Scemblix
Published
Product name
Scemblix
Active ingredient
Asciminib
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Scemblix (asciminib) was approved for the following therapeutic use:
Scemblix is indicated for the treatment of patients 18 years of age and above with:
- Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 Clinical trials).
- Ph+ CML in CP with the T315I mutation.
How this medicine works
Asciminib is an oral and potent inhibitor of Abelson nonreceptor tyrosine kinases/breakpoint cluster region (ABL/BCR): ABL1 tyrosine kinases. Asciminib inhibits the ABL1 kinase activity of the BCR: ABL1 fusion protein, by specifically targeting the ABL myristoyl pocket.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Scemblix was considered favourable for the therapeutic use approved.