{"entity":{"id":"niraparib","kind":"drug","name":"Niraparib","aka":["Niraparib Tosylate Monohydrate and Abiraterone Acetate","Akeega"],"tldr":"Niraparib is a PARP inhibitor approved as maintenance for ovarian cancer regardless of BRCA status, and in prostate cancer with abiraterone.","summary":"Niraparib is a PARP1/2 inhibitor that traps PARP on damaged DNA, killing tumour cells that cannot repair double-strand breaks through homologous recombination. It was approved in 2017 for maintenance in recurrent ovarian cancer (NOVA) and in 2020 for first-line maintenance regardless of BRCA status (PRIMA) (label later restricted to HRD-positive in some settings). Combined with abiraterone as Akeega, it is approved for BRCA-mutant metastatic castration-resistant prostate cancer (MAGNITUDE, 2023). Dosing is individualised at 200 or 300 mg daily by weight and platelet count, for up to 3 years in first-line maintenance; thrombocytopenia (66%, 38% grade 3 or higher) and anaemia are the main toxicities, and MDS or AML occurs in 3.3%. Whether HRD-negative patients gain survival remains contested. For a newcomer: a PARP pill that stretched maintenance therapy beyond BRCA carriers.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Niraparib","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Niraparib"},{"label":"NICE TA1032: niraparib with abiraterone acetate and prednisone for untreated hormone-relapsed metastatic prostate cancer, terminated appraisal","url":"https://www.nice.org.uk/guidance/terminated/ta1032"}],"tags":[],"related":["brca-germline","hrd-positive"],"cancers":["ovarian","prostate","high-grade-serous-ovarian-cancer","prostate-mcrpc","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":["parp"],"drugs":[],"companies":["gsk"],"institutions":[],"pathways":[],"terms":["prostate-hrr-eligibility","prostate-uk-drug-approvals"],"trials":["nct06915025","nct05335993","nct04915755","nct03431350","nct06682780","nct04497844","nct03602859","nct04641247","nct06077877"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Niraparib with abiraterone acetate and prednisone has no NICE recommendation for prostate cancer in England. TA1032, terminated on 22 January 2025, records that NICE was unable to make a recommendation because Johnson and Johnson Innovative Medicine did not provide an evidence submission; the decision will be reviewed if the company submits."],"brand":"Zejula","modality":"Small-molecule PARP inhibitor","mechanism":"PARP1/2 inhibitor.","approvals":[{"region":"US","year":2017,"indication":"Recurrent ovarian cancer maintenance"},{"region":"US","year":2020,"indication":"First-line ovarian maintenance"}],"mechanismSteps":["Niraparib binds and traps PARP1/2 on damaged DNA","Single-strand break repair fails; forks collapse","HR-deficient cells accumulate lethal double-strand breaks","Tumour cells die; marrow suppression is the main collateral effect"],"dosing":{"route":"Oral","schedule":"200 mg once daily if <77 kg or platelets <150,000/µL; otherwise 300 mg once daily; 3 years first-line maintenance","modifications":"Reduce for thrombocytopenia; hold for hypertension crisis","monitoring":"Blood counts weekly for the first month, monthly for 11 months; blood pressure; MDS/AML awareness","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7f675e2-159c-490c-b6f4-3f16d9492b7d"},"toxicity":[{"event":"Thrombocytopenia","anyGradePct":66,"grade3PlusPct":38,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7f675e2-159c-490c-b6f4-3f16d9492b7d","note":"PRIMA"},{"event":"Anaemia","anyGradePct":65,"grade3PlusPct":31,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7f675e2-159c-490c-b6f4-3f16d9492b7d","note":"PRIMA"},{"event":"Nausea","anyGradePct":62,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7f675e2-159c-490c-b6f4-3f16d9492b7d","note":"PRIMA"},{"event":"Fatigue","anyGradePct":52,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7f675e2-159c-490c-b6f4-3f16d9492b7d","note":"PRIMA"},{"event":"Neutropenia","grade3PlusPct":17,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7f675e2-159c-490c-b6f4-3f16d9492b7d","note":"PRIMA"},{"event":"MDS/AML","anyGradePct":3.3,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7f675e2-159c-490c-b6f4-3f16d9492b7d","note":"vs 2.4% placebo, PRIMA long-term"}],"access":[{"country":"US","reimbursement":"Medicare Part D (oral); commercial plans per formulary, often with prior authorisation","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended for ovarian maintenance (TA528, TA673) and with abiraterone in BRCA-mutant prostate cancer (Akeega)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2017-03-27","type":"approval","region":"US","note":"Maintenance in recurrent ovarian cancer regardless of BRCA (NOVA)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2020-04-29","type":"approval","region":"US","note":"First-line ovarian maintenance, all-comers (PRIMA)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2022-11","type":"label-change","region":"US","note":"Second-line maintenance restricted to gBRCA after OS data","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2023-08-11","type":"approval","region":"US","note":"Niraparib + abiraterone (Akeega) for BRCA-mutated mCRPC (MAGNITUDE)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/niraparib/","neighbours":{"biomarker":[{"id":"brca-germline","kind":"biomarker","name":"Germline BRCA1/2 pathogenic variant (gBRCAm)","route":"/biomarkers/brca-germline/"},{"id":"hrr-gene-mutation","kind":"biomarker","name":"Homologous recombination repair gene mutation in prostate cancer","route":"/biomarkers/hrr-gene-mutation/"},{"id":"hrd-positive","kind":"biomarker","name":"HRD-positive (genomic instability score)","route":"/biomarkers/hrd-positive/"},{"id":"brca-somatic","kind":"biomarker","name":"Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations","route":"/biomarkers/brca-somatic/"}],"cancer":[{"id":"brca-palb2-pdac","kind":"cancer","name":"BRCA or PALB2-mutant pancreatic ductal adenocarcinoma","route":"/cancers/brca-palb2-pdac/"},{"id":"high-grade-serous-ovarian-cancer","kind":"cancer","name":"High-grade serous ovarian cancer","route":"/cancers/high-grade-serous-ovarian-cancer/"},{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"platinum-sensitive-ovarian-cancer","kind":"cancer","name":"Platinum-sensitive ovarian cancer","route":"/cancers/platinum-sensitive-ovarian-cancer/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"hrd-genomic-scar-scores","kind":"technology","name":"HRD genomic scar scores (GIS, LOH, HRDetect)","route":"/technologies/hrd-genomic-scar-scores/"},{"id":"parp-inhibitor","kind":"technology","name":"PARP inhibitors","route":"/technologies/parp-inhibitor/"},{"id":"rad51-foci-assay","kind":"technology","name":"RAD51 foci assay (functional HRD test)","route":"/technologies/rad51-foci-assay/"}],"target":[{"id":"parp","kind":"target","name":"PARP","route":"/targets/parp/"}],"company":[{"id":"arcagy-gineco","kind":"company","name":"ARCAGY-GINECO","route":"/companies/arcagy-gineco/"},{"id":"gsk","kind":"company","name":"GSK","route":"/companies/gsk/"},{"id":"zai-lab","kind":"company","name":"Zai Lab","route":"/companies/zai-lab/"}],"term":[{"id":"brca-reversion-mutations","kind":"term","name":"BRCA reversion mutations","route":"/terms/brca-reversion-mutations/"},{"id":"biomarker-stratified-design","kind":"term","name":"Enrichment and biomarker-stratified designs","route":"/terms/biomarker-stratified-design/"},{"id":"genome-wide-loss-of-heterozygosity","kind":"term","name":"Genome-wide loss of heterozygosity (gLOH)","route":"/terms/genome-wide-loss-of-heterozygosity/"},{"id":"maintenance-therapy","kind":"term","name":"Maintenance therapy","route":"/terms/maintenance-therapy/"},{"id":"rejuv-second-platinum-and-parp-inhibitors","kind":"term","name":"Platinum drugs and PARP inhibitors: the newer leukaemia risk","route":"/terms/rejuv-second-platinum-and-parp-inhibitors/"},{"id":"prostate-uk-drug-approvals","kind":"term","name":"Prostate cancer drugs in England: what NICE recommends, and what it refuses","route":"/terms/prostate-uk-drug-approvals/"},{"id":"prostate-hrr-eligibility","kind":"term","name":"Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters","route":"/terms/prostate-hrr-eligibility/"}],"trial":[{"id":"nct05335993","kind":"trial","name":"A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.","route":"/trials/nct05335993/"},{"id":"nct03602859","kind":"trial","name":"A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer","route":"/trials/nct03602859/"},{"id":"nct04641247","kind":"trial","name":"A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study","route":"/trials/nct04641247/"},{"id":"nct06682780","kind":"trial","name":"A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours","route":"/trials/nct06682780/"},{"id":"nct06953323","kind":"trial","name":"A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors","route":"/trials/nct06953323/"},{"id":"nct03431350","kind":"trial","name":"A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer","route":"/trials/nct03431350/"},{"id":"nct04497844","kind":"trial","name":"A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-MutatedProstatic Neoplasms (mCSPC)","route":"/trials/nct04497844/"},{"id":"nct06077877","kind":"trial","name":"A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors","route":"/trials/nct06077877/"},{"id":"nct04915755","kind":"trial","name":"Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease","route":"/trials/nct04915755/"},{"id":"magnitude","kind":"trial","name":"MAGNITUDE","route":"/trials/magnitude/"},{"id":"nct06747845","kind":"trial","name":"Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy","route":"/trials/nct06747845/"},{"id":"nct05718323","kind":"trial","name":"Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC","route":"/trials/nct05718323/"},{"id":"nct06915025","kind":"trial","name":"Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Pat","route":"/trials/nct06915025/"},{"id":"prima","kind":"trial","name":"PRIMA / ENGOT-OV26","route":"/trials/prima/"},{"id":"safir-abc10","kind":"trial","name":"SAFIR-ABC10","route":"/trials/safir-abc10/"}],"idea":[{"id":"idea-ctdna-guided-parp-duration","kind":"idea","name":"ctDNA-guided duration of PARP maintenance","route":"/ideas/idea-ctdna-guided-parp-duration/"},{"id":"idea-tr1-start-low-titrate-up-oral-agents","kind":"idea","name":"Start low and step up: individualised titration of oral cancer drugs, randomised","route":"/ideas/idea-tr1-start-low-titrate-up-oral-agents/"},{"id":"idea-prostate-hrr-testing-at-metastatic-diagnosis","kind":"idea","name":"Test every man for DNA repair faults on the day his prostate cancer is found to have spread, not three treatments later","route":"/ideas/idea-prostate-hrr-testing-at-metastatic-diagnosis/"}],"pathway":[{"id":"ar-signaling","kind":"pathway","name":"Androgen receptor signalling","route":"/pathways/ar-signaling/"},{"id":"base-excision-repair-parp","kind":"pathway","name":"Base excision repair, PARP & alkylation damage","route":"/pathways/base-excision-repair-parp/"},{"id":"ddr","kind":"pathway","name":"DNA damage response & homologous recombination","route":"/pathways/ddr/"},{"id":"homologous-recombination-repair","kind":"pathway","name":"Double-strand break repair: HR versus end joining","route":"/pathways/homologous-recombination-repair/"},{"id":"prostate-cancer-signalling","kind":"pathway","name":"Prostate cancer (KEGG map)","route":"/pathways/prostate-cancer-signalling/"},{"id":"synthetic-lethality-map","kind":"pathway","name":"Synthetic lethality: paired dependencies","route":"/pathways/synthetic-lethality-map/"}],"pairing":[{"id":"parp-plus-arpi","kind":"pairing","name":"PARP inhibitor + AR pathway inhibitor (prostate)","route":"/pairings/parp-plus-arpi/"}],"person":[{"id":"amit-oza","kind":"person","name":"Amit M. Oza","route":"/people/amit-oza/"},{"id":"kim-chi","kind":"person","name":"Kim N. Chi","route":"/people/kim-chi/"},{"id":"mansoor-raza-mirza","kind":"person","name":"Mansoor Raza Mirza","route":"/people/mansoor-raza-mirza/"}],"paper":[{"id":"paper-drug-dosing-conundrum-nejm-2021","kind":"paper","name":"FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high","route":"/key-papers/paper-drug-dosing-conundrum-nejm-2021/"},{"id":"paper-prima-niraparib-nejm-2019","kind":"paper","name":"PRIMA: niraparib maintenance in newly diagnosed advanced ovarian cancer","route":"/key-papers/paper-prima-niraparib-nejm-2019/"}],"drug":[{"id":"mychoice-cdx","kind":"drug","name":"myChoice CDx","route":"/drugs/mychoice-cdx/"}]}}