TALZENNA

What it is

TALZENNA is available in five strengths: 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg and 1 mg capsules, each containing talazoparib as the tosilate salt. TALZENNA is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, including PARP1 and PARP2, which play a role in DNA repair.

Approved indications

— Treatment of patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA) mutation who have human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. — In combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

Dosing overview

TALZENNA may be taken with or without food. The capsules should be swallowed whole and must not be opened or dissolved. Patients should be treated until disease progression or unacceptable toxicity occurs.

Key safety warnings

Myelodysplastic syndrome and acute myeloid leukaemia (MDS/AML) have been reported in patients who received talazoparib, with overall MDS/AML reported in less than 1% of solid tumour patients treated with talazoparib in clinical studies. Do not start TALZENNA until patients have adequately recovered from haematological toxicity caused by previous chemotherapy. Monitor full blood counts for cytopenia at baseline and monthly thereafter. Myelosuppression, consisting of anaemia, leucopenia/neutropenia and/or thrombocytopenia, is very common in patients treated with talazoparib. In TALAPRO-2, Grade 3 or higher anaemia, neutropenia, and thrombocytopenia were reported, respectively, in 45%, 18%, and 8% of patients receiving TALZENNA and enzalutamide. Overall, 39% of patients required a red blood cell transfusion, including 22% who required multiple transfusions. Based on its mechanism of action and findings from animal data, TALZENNA can cause fetal harm when administered to a pregnant woman. In an animal reproduction study, administration of talazoparib to pregnant rats during organogenesis caused fetal malformations and embryo-fetal death. Conduct a blood test for pregnancy prior to initiating TALZENNA treatment in any female of reproductive potential. Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of TALZENNA.

Contraindications

Use of TALZENNA is contraindicated in patients with hypersensitivity to talazoparib tosilate or any of the excipients.

PBS listing

TALZENNA was recommended by the PBAC in July 2024 for prostate cancer (in combination with enzalutamide, for the first line treatment of metastatic castration resistant prostate cancer in patients with a BRCA1 or BRCA2 mutation who have not received prior treatment with a novel hormonal agent).

Regulatory history

TALZENNA was first approved on 18 November 2019. Initial ARTG registrations on 18 November 2019 included the 1 mg and 0.25 mg strengths in both bottle and blister pack presentations. Additional strengths (0.1 mg, 0.35 mg and 0.5 mg in bottle presentations) were registered on 14 August 2024. The PBAC initially did not recommend TALZENNA for prostate cancer in March 2024, but recommended it in July 2024 for first-line treatment of metastatic castration-resistant prostate cancer in patients with BRCA1 or BRCA2 mutations who had not received prior novel hormonal agent treatment.