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Brukinsa
Published
Product name
Brukinsa
Active ingredient
Zanubrutinib
Submission type
New chemical entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Brukinsa (zanubrutinib) was approved for the following therapeutic use:
Mantle cell lymphoma (MCL)
Brukinsa is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
This indication was approved via the provisional approval pathway, based on objective response rate. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.
How this medicine works
Zanubrutinib is a small molecule inhibitor of Bruton's tyrosine kinase (BTK). Zanubrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK 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, zanubrutinib inhibited malignant B-cell proliferation and reduced tumour growth.
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 Brukinsa was considered favourable for the therapeutic use approved.
Sponsor
ARTG details