Lynparza (olaparib; AstraZeneca/Merck & Co) is a small molecule poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of BRCA mutation-positive (BRCAm+) ovarian cancer. The PARP enzyme plays an essential role in DNA repair mechanisms and homologous recombination events. PARP inhibitors act 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.
BRCA1 and BRCA2 encode proteins that are required for DNA damage repair. Inherited mutations in these genes 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.
CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Lynparza : Breast cancer: triple-negative
13 Lynparza : Prostate cancer
25 Lynparza : Ovarian cancer
44 Lynparza : Breast cancer: HR+/HER2-
LIST OF FIGURES
11 Figure 1: Datamonitor Healthcare’s drug assessment summary of Lynparza for TNBC
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of Lynparza for TNBC
18 Figure 3: Lynparza for prostate cancer – SWOT analysis
19 Figure 4: Datamonitor Healthcare’s drug assessment summary of Lynparza for prostate cancer
20 Figure 5: Datamonitor Healthcare’s drug assessment summary of Lynparza for prostate cancer
22 Figure 6: Lynparza sales for prostate cancer across the US, Japan, and five major EU markets, by country, 2017–26
36 Figure 7: Lynparza for ovarian cancer – SWOT analysis
37 Figure 8: Datamonitor Healthcare’s drug assessment of Lynparza for ovarian cancer
38 Figure 9: Datamonitor Healthcare’s drug assessment of Lynparza for ovarian cancer
48 Figure 10: Lynparza for HR+/HER2- breast cancer – SWOT analysis
49 Figure 11: Datamonitor Healthcare’s drug assessment summary of Lynparza in HR+/HER2- breast cancer
50 Figure 12: Datamonitor Healthcare’s drug assessment summary of Lynparza in HR+/HER2- breast cancer
LIST OF TABLES
7 Table 1: Lynparza drug profile
8 Table 2: Approval history of Lynparza for TNBC in the US, Japan, and five major European markets
9 Table 3: Late-phase trials of Lynparza for TNBC
10 Table 4: Lynparza for TNBC – SWOT analysis
14 Table 5: Lynparza drug profile
15 Table 6: Lynparza Phase III trial in prostate cancer
17 Table 7: Lynparza Phase II data in prostate cancer
23 Table 8: Lynparza sales for prostate cancer across the US, Japan, and five major EU markets, by country ($m), 2017–26
26 Table 9: Lynparza drug profile
28 Table 10: Lynparza pivotal trial data in ovarian cancer
32 Table 11: Lynparza ongoing late-phase clinical trials in ovarian cancer
35 Table 12: Overview of early-phase data for Lynparza in ovarian cancer
45 Table 13: Lynparza drug profile
46 Table 14: Lynparza Phase III trial in HR+/HER2- breast cancer
47 Table 15: Lynparza Phase II data in HR+/HER2- breast cancer
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