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Title Zejula (niraparib) FDA Drug Label
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URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208447
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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Niraparib Niraparib 6 25
Drug Name Trade Name Synonyms Drug Classes Drug Description
Niraparib Zejula MK4827 PARP Inhibitor (Pan) 20 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