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Niraparib is a PARP inhibitor approved as maintenance for ovarian cancer regardless of BRCA status, and in prostate cancer with abiraterone.
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.
PARP1/2 inhibitor. Connects to PARP.
1.Niraparib binds and traps PARP1/2 on damaged DNA
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). Akeega (niraparib + abiraterone) is also Part D.
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA528 · NHS England Cancer Drugs Fund list · SMC advice: niraparib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Maintenance in recurrent ovarian cancer regardless of BRCA (NOVA) source
First-line ovarian maintenance, all-comers (PRIMA) source
Second-line maintenance restricted to gBRCA after OS data source
Niraparib + abiraterone (Akeega) for BRCA-mutated mCRPC (MAGNITUDE) source
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Recurrent ovarian cancer maintenance |
| US | 2020 | First-line ovarian maintenance |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Thrombocytopenia PRIMA | 66% | 38% |
| Anaemia PRIMA | 65% | 31% |
| Nausea PRIMA | 62% | - |
| Fatigue PRIMA | 52% | - |
| Neutropenia PRIMA | - | 17% |
| MDS/AML vs 2.4% placebo, PRIMA long-term | 3.3% | - |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (parp inhibitors) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | - |
| United Kingdom | NICE: recommended for ovarian maintenance (TA528, TA673) and with abiraterone in BRCA-mutant prostate cancer (Akeega) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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The dose on the label is often not the best dose for patients; it is the highest one that was tolerable for a few weeks. Project Optimus means new cancer drugs should arrive with evidence on dose, and it gives clinicians licence to consider dose reduction for toxicity. For older drugs, the evidence gap persists.
Niraparib is approved as first-line maintenance for all comers, making PARP inhibitor maintenance available beyond BRCA-mutated disease, though the benefit in proficient tumours is modest and long-term survival data are neutral.
Query for this drug: (TITLE:"Niraparib" OR ABSTRACT:"Niraparib" OR TITLE:"Zejula" OR ABSTRACT:"Zejula" OR TITLE:"Niraparib Tosylate Monohydrate and Abiraterone Acetate" OR ABSTRACT:"Niraparib Tosylate Monohydrate and Abiraterone Acetate" OR TITLE:"Akeega" OR ABSTRACT:"Akeega") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Niraparib, not a curated reading list.
Shares Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters, BRCA reversion mutations, RAD51 foci assay (functional HRD test), Genome-wide loss of heterozygosity (gLOH).
Shares PARP inhibitor + AR pathway inhibitor (prostate), Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters, RAD51 foci assay (functional HRD test), Genome-wide loss of heterozygosity (gLOH).
Shares PRIMA / ENGOT-OV26, ARCAGY-GINECO, Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters, myChoice CDx.
Shares Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Pat, Amit M. Oza, PARP inhibitor + AR pathway inhibitor (prostate), ctDNA-guided duration of PARP maintenance.
Shares Genome-wide loss of heterozygosity (gLOH), Base excision repair, PARP & alkylation damage, Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations, Test every man for DNA repair faults on the day his prostate cancer is found to have spread, not three treatments later.
Shares BRCA reversion mutations, Base excision repair, PARP & alkylation damage, Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations, Homologous recombination repair gene mutation in prostate cancer.
Shares ARCAGY-GINECO, myChoice CDx, RAD51 foci assay (functional HRD test), HRD genomic scar scores (GIS, LOH, HRDetect).
Shares ARCAGY-GINECO, myChoice CDx, HRD genomic scar scores (GIS, LOH, HRDetect), High-grade serous ovarian cancer.