Zejula
Author: Zachary McLellan
Publisher: Datamonitor Healthcare
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Drug Overview
Zejula (niraprib; Tesaro/Takeda) 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 a cytotoxic chemotherapy which works by damaging DNA.
Inherited mutations in BRCA1 and BRCA2 have been linked to a predisposition towards the development of breast and ovarian cancers. In the US, it has been estimated that inherited BRCA1 and BRCA2 mutations account for 5–10% of breast cancers and 10–15% of ovarian cancers among white women.
TABLE OF CONTENTS
4 Product Profiles
4 Zejula : Ovarian cancer
18 niraparib : Breast cancer: triple-negative
26 niraparib : Breast cancer: HR+/HER2-
LIST OF FIGURES
12 Figure 1: Zejula for ovarian cancer – SWOT analysis
13 Figure 2: Datamonitor Healthcare’s drug assessment of Zejula for ovarian cancer
14 Figure 3: Datamonitor Healthcare’s drug assessment of Zejula for ovarian cancer
21 Figure 4: Niraparib for triple-negative breast cancer – SWOT analysis
22 Figure 5: Datamonitor Healthcare’s drug assessment summary of niraparib for triple-negative breast cancer
23 Figure 6: Datamonitor Healthcare’s drug assessment summary of niraparib for triple-negative breast cancer
29 Figure 7: Niraparib for HR+/HER2- breast cancer – SWOT analysis
30 Figure 8: Datamonitor Healthcare’s drug assessment summary of niraparib in HR+/HER2- breast cancer
31 Figure 9: Datamonitor Healthcare’s drug assessment summary of niraparib in HR+/HER2- breast cancer
LIST OF TABLES
5 Table 1: Zejula drug profile
7 Table 2: Zejula pivotal trial data in ovarian cancer
10 Table 3: Zejula ongoing late-phase trials in ovarian cancer
12 Table 4: Early-phase data for Zejula in ovarian cancer
19 Table 5: Niraparib drug profile
20 Table 6: Niraparib Phase III trial in triple-negative breast cancer
20 Table 7: Niraparib Phase I data in triple-negative breast cancer
27 Table 8: Niraparib drug profile
28 Table 9: Niraparib Phase III trial in HR+/HER2- breast cancer
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