# Niraparib

Source: https://onco.cc/drugs/niraparib/  
OnCo record `niraparib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Also known as: Niraparib Tosylate Monohydrate and Abiraterone Acetate; Akeega
- Brand: Zejula
- Modality: Small-molecule PARP inhibitor
- Mechanism: PARP1/2 inhibitor.
- Approvals: US 2017: Recurrent ovarian cancer maintenance; US 2020: First-line ovarian maintenance
- Dosing: Oral; 200 mg once daily if <77 kg or platelets <150,000/µL; otherwise 300 mg once daily; 3 years first-line maintenance
- Toxicity (grade 3+): Thrombocytopenia 38%; Anaemia 31%; Neutropenia 17%

## 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.

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Niraparib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Niraparib
- NICE TA1032: niraparib with abiraterone acetate and prednisone for untreated hormone-relapsed metastatic prostate cancer, terminated appraisal: https://www.nice.org.uk/guidance/terminated/ta1032

## Connected records

- biomarkers: [Germline BRCA1/2 pathogenic variant (gBRCAm)](https://onco.cc/biomarkers/brca-germline/), [Homologous recombination repair gene mutation in prostate cancer](https://onco.cc/biomarkers/hrr-gene-mutation/), [HRD-positive (genomic instability score)](https://onco.cc/biomarkers/hrd-positive/), [Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations](https://onco.cc/biomarkers/brca-somatic/)
- cancers: [BRCA or PALB2-mutant pancreatic ductal adenocarcinoma](https://onco.cc/cancers/brca-palb2-pdac/), [High-grade serous ovarian cancer](https://onco.cc/cancers/high-grade-serous-ovarian-cancer/), [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Platinum-sensitive ovarian cancer](https://onco.cc/cancers/platinum-sensitive-ovarian-cancer/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [HRD genomic scar scores (GIS, LOH, HRDetect)](https://onco.cc/technologies/hrd-genomic-scar-scores/), [PARP inhibitors](https://onco.cc/technologies/parp-inhibitor/), [RAD51 foci assay (functional HRD test)](https://onco.cc/technologies/rad51-foci-assay/)
- targets: [PARP](https://onco.cc/targets/parp/)
- companies: [ARCAGY-GINECO](https://onco.cc/companies/arcagy-gineco/), [GSK](https://onco.cc/companies/gsk/), [Zai Lab](https://onco.cc/companies/zai-lab/)
- terms: [BRCA reversion mutations](https://onco.cc/terms/brca-reversion-mutations/), [Enrichment and biomarker-stratified designs](https://onco.cc/terms/biomarker-stratified-design/), [Genome-wide loss of heterozygosity (gLOH)](https://onco.cc/terms/genome-wide-loss-of-heterozygosity/), [Maintenance therapy](https://onco.cc/terms/maintenance-therapy/), [Platinum drugs and PARP inhibitors: the newer leukaemia risk](https://onco.cc/terms/rejuv-second-platinum-and-parp-inhibitors/), [Prostate cancer drugs in England: what NICE recommends, and what it refuses](https://onco.cc/terms/prostate-uk-drug-approvals/), [Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters](https://onco.cc/terms/prostate-hrr-eligibility/)
- trials: [A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.](https://onco.cc/trials/nct05335993/), [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](https://onco.cc/trials/nct03602859/), [A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study](https://onco.cc/trials/nct04641247/), [A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours](https://onco.cc/trials/nct06682780/), [A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors](https://onco.cc/trials/nct06953323/), [A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer](https://onco.cc/trials/nct03431350/), [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)](https://onco.cc/trials/nct04497844/), [A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors](https://onco.cc/trials/nct06077877/), [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](https://onco.cc/trials/nct04915755/), [MAGNITUDE](https://onco.cc/trials/magnitude/), [Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy](https://onco.cc/trials/nct06747845/), [Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC](https://onco.cc/trials/nct05718323/), [Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Pat](https://onco.cc/trials/nct06915025/), [PRIMA / ENGOT-OV26](https://onco.cc/trials/prima/), [SAFIR-ABC10](https://onco.cc/trials/safir-abc10/)
- ideas: [ctDNA-guided duration of PARP maintenance](https://onco.cc/ideas/idea-ctdna-guided-parp-duration/), [Start low and step up: individualised titration of oral cancer drugs, randomised](https://onco.cc/ideas/idea-tr1-start-low-titrate-up-oral-agents/), [Test every man for DNA repair faults on the day his prostate cancer is found to have spread, not three treatments later](https://onco.cc/ideas/idea-prostate-hrr-testing-at-metastatic-diagnosis/)
- pathways: [Androgen receptor signalling](https://onco.cc/pathways/ar-signaling/), [Base excision repair, PARP & alkylation damage](https://onco.cc/pathways/base-excision-repair-parp/), [DNA damage response & homologous recombination](https://onco.cc/pathways/ddr/), [Double-strand break repair: HR versus end joining](https://onco.cc/pathways/homologous-recombination-repair/), [Prostate cancer (KEGG map)](https://onco.cc/pathways/prostate-cancer-signalling/), [Synthetic lethality: paired dependencies](https://onco.cc/pathways/synthetic-lethality-map/)
- pairings: [PARP inhibitor + AR pathway inhibitor (prostate)](https://onco.cc/pairings/parp-plus-arpi/)
- people: [Amit M. Oza](https://onco.cc/people/amit-oza/), [Kim N. Chi](https://onco.cc/people/kim-chi/), [Mansoor Raza Mirza](https://onco.cc/people/mansoor-raza-mirza/)
- key papers: [FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high](https://onco.cc/key-papers/paper-drug-dosing-conundrum-nejm-2021/), [PRIMA: niraparib maintenance in newly diagnosed advanced ovarian cancer](https://onco.cc/key-papers/paper-prima-niraparib-nejm-2019/)
- drugs: [myChoice CDx](https://onco.cc/drugs/mychoice-cdx/)

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JSON: https://onco.cc/api/v1/entities/niraparib.json