Talzenna (talazoparib; Pfizer) is a small-molecule inhibitor of poly (ADP-ribose) polymerase (PARP). PARP inhibitors block the activity of PARP, an enzyme that plays an essential role in DNA repair mechanisms and homologous recombination events, by directly blocking enzymatic activity, or by causing PARP to accumulate on DNA (PARP trapping), which results in DNA replication inhibition and cell death. Tumor cells with BRCA1/2 gene mutations are dependent on PARP for DNA damage repair, and PARP inhibition selectively kills BRCA1- or BRCA2-deficient cells. As DNA repair is inhibited by PARP inhibitors, they are often sequenced after cytotoxic chemotherapy, which works by damaging DNA.
BRCA1 and BRCA2 encode proteins that are required for DNA damage repair. Inherited mutations in these genes have been linked to a predisposition for the development of breast and ovarian cancers. Approximately 11–16% of patients with triple-negative breast cancer have a deleterious BRCA1 or BRCA2 mutation.
4 Drug Overview
5 Product Profiles
5 Talzenna : Breast cancer: triple-negative
12 talazoparib : Breast cancer: HR+/HER2-
LIST OF FIGURES
10 Figure 1: Datamonitor Healthcare’s drug assessment summary of Talzenna for TNBC
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Talzenna for TNBC
16 Figure 3: Talazoparib for HR+/HER2- breast cancer – SWOT analysis
17 Figure 4: Datamonitor Healthcare’s drug assessment summary of talazoparib in HR+/HER2- breast cancer
18 Figure 5: Datamonitor Healthcare’s drug assessment summary of talazoparib in HR+/HER2- breast cancer
LIST OF TABLES
5 Table 1: Recent high-impact events for Talzenna in TNBC
6 Table 2: Talzenna drug profile
7 Table 3: Approval history of Talzenna for TNBC in the US, Japan, and five major European markets
8 Table 4: Late-phase trials of Talzenna for TNBC
9 Table 5: Talzenna for TNBC – SWOT analysis
13 Table 6: Talazoparib drug profile
14 Table 7: Talazoparib Phase III trial in HR+/HER2- breast cancer
15 Table 8: Talazoparib Phase I data in HR+/HER2- breast cancer
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