Talazoparib (Talzenna)

Mechanism of action

PARP inhibitor

• IUPHAR/BPS

Diseases for which it is used

• BRCA-mutated breast cancer
• Prostate cancer

History of changes in FDA indication

• 2018-10-16: Initial approval for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer. (Based on EMBRACA)
• 2023-06-20: Approved with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). (Based on TALAPRO-2)

History of changes in EMA indication

• 2019-06-20: Initial authorization as Talzenna. Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy. (Based on EMBRACA)
• 2023-11-09: CHMP recommends new marketing authorisation - Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

History of changes in PMDA indication

• 2024-01-18: Newly indicated for the treatment of BRCA mutation-positive, metastatic castration-resistant prostate cancer.
• 2024-01-18: Newly indicated for the treatment of unresectable or recurrent BRCA mutation-positive and HER2-negative breast cancer in patients who have previously been treated with chemotherapy.

Also known as

• Code name: BMN-673
• Brand name: Talzenna