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Talzenna
Published
Product name
Talzenna
Active ingredient
Talazoparib (as tosilate)
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Talzenna (talazoparib as tosilate) was approved for the following therapeutic use:
Talzenna is indicated for the treatment of patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA) mutation according to a validated diagnostic test, who have human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.
How this medicine works
Talazoparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1 and PARP2, which play a role in DNA repair. In vitro studies with cancer cell lines that harboured defects in DNA repair genes, including breast cancer susceptibility gene (BRCA) 1 and 2, have shown that talazoparib induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, decreased cell proliferation and apoptosis. Talazoparib anti-tumour activity was observed in human patient-derived xenograft breast cancer tumour models that expressed mutated or wild-type BRCA 1 and 2.
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 Talzenna was considered favourable for the therapeutic use approved.
Sponsor