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TALZENNA (Pfizer Australia Pty Ltd)
Product name
TALZENNA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
243 (255 working days)
Active ingredients
talazoparib tosilate
Registration type
EOI
Indication
Breast Cancer
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.
Prostate Cancer
TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).