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|Title||Zejula (niraparib) FDA Drug Label|
|Molecular Profile||Treatment Approach|
|Gene Name||Source||Synonyms||Protein Domains||Gene Description||Gene Role|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Niraparib||Zejula||MK4827||PARP Inhibitor (Pan) 22||Zejula (niraparib) binds and inhibits PARP, which may result in accumulation of DNA damage and apoptosis of tumor cells (PMID: 23810788). Zejula (niraparib) is FDA-approved as maintenance therapy in patients with recurrent or newly-diagnosed epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to platinum-based chemotherapy, and in ovarian, fallopian tube, or primary peritoneal cancer that received 3 or more chemotherapies and is homologous recombination deficient as indicated by either a deleterious or suspected deleterious BRCA mutation, or genomic instability and progressed 6 months or more after response to last platinum-based chemotherapy (FDA.gov).|
|Gene||Variant||Impact||Protein Effect||Variant Description||Associated with drug Resistance|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||ovary epithelial cancer||not applicable||Niraparib||FDA approved||Actionable||In a Phase III trial (PRIMA) that supported FDA approval, maintenance therapy with Zejula (niraparib) significantly improved progression-free survival compared to placebo in homologous-recombination deficient (21.9 vs 10.4 months, HR=0.43, p<0.001) and the overall (13.8 vs 8.2 months, HR=0.62, p<0.001) populations of patients with newly diagnosed advanced epithelial ovarian, fallopian tube, and primary peritoneal cancer who had a response to platinum-based chemotherapy (PMID: 31562799; NCT02655016).||31562799 detail...|
|Unknown unknown||ovary epithelial cancer||not applicable||Niraparib||FDA approved||Actionable||In a Phase III trial (NOVA) that supported FDA approval, maintenance therapy with Zejula (niraparib) improved median progression-free survival compared to placebo in germline BRCA mutant (21.0 vs. 5.5 mo., HR=0.27) and germline BRCA wild-type (9.3 vs. 3.9 mo, HR=0.45) patients with recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer, who had a complete or partial response to 2 or more prior platinum therapies (PMID: 27717299; NCT01847274).||detail... 27717299|