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Calquence
Published
Product name
Calquence
Active ingredient
Acalabrutinib
Submission type
New chemical entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Calquence (acalabrutinib) was provisionally approved for the following therapeutic use:
Calquence is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
This indication is approved via the provisional approval pathway, based on overall response rate. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.
The provisional registration period for the above medicine is two years starting on the day specified in the ARTG certificate of registration.
How this medicine works
Acalabrutinib is a small-molecule inhibitor of Bruton tyrosine kinase (BTK). Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signalling molecule of the B cell antigen receptor (BCR) and cytokine receptor pathways. In B cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, acalabrutinib inhibited BTK-mediated activation of downstream signalling proteins cluster of differentiation 86 (CD86) and CD69 and inhibited malignant B-cell proliferation and survival.
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 Calquence was considered favourable for the therapeutic use approved.
Sponsor