Niraparib
Niraparib is a PARP inhibitor approved as maintenance for ovarian cancer regardless of BRCA status, and in prostate cancer with abiraterone.
NOVA and PRIMA (first-line maintenance, all-comers; label later restricted to HRD+ in some settings); Akeega (niraparib + abiraterone) for BRCA-mutant mCRPC (MAGNITUDE, 2023). GSK.
1.Niraparib binds and traps PARP1/2 on damaged DNA
- 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
- Dose 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: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Together with GSK Oncology
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Appraised for
- Maintenance for relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer
- Notes
- First-line maintenance after platinum (PRIMA): TA673 (2021, CDF then routine). Both indications now routinely commissioned regardless of BRCA status.
- Cancer Drugs Fund
- Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
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.
- 27 Mar 2017ApprovalUS
Maintenance in recurrent ovarian cancer regardless of BRCA (NOVA) source
- 29 Apr 2020ApprovalUS
First-line ovarian maintenance, all-comers (PRIMA) source
- Nov 2022Label changeUS
Second-line maintenance restricted to gBRCA after OS data source
- 11 Aug 2023ApprovalUS
Niraparib + abiraterone (Akeega) for BRCA-mutated mCRPC (MAGNITUDE) source
Approvals
| 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.
| 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.
Trials
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Latest papers
topQuery for this drug: (TITLE:"Niraparib" OR ABSTRACT:"Niraparib" OR TITLE:"Zejula" OR ABSTRACT:"Zejula") 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.
Pages like this
not linked directly; found by shared links- ProductTalazoparib
Shares PARP inhibitor + AR pathway inhibitor (prostate), Base excision repair, PARP & alkylation damage, Androgen receptor signalling, DNA damage response & homologous recombination.
- ProductOlaparib
Shares Amit M. Oza, ctDNA-guided duration of PARP maintenance, PARP inhibitor + AR pathway inhibitor (prostate), Maintenance therapy.
- TechnologyHRD & BRCA testing
Shares ARCAGY-GINECO, DNA damage response & homologous recombination, Synthetic lethality: paired dependencies, Double-strand break repair: HR versus end joining.
- ProductRucaparib
Shares Base excision repair, PARP & alkylation damage, Double-strand break repair: HR versus end joining, PARP inhibitors, PARP.
- TrialSOLO-1
Shares ctDNA-guided duration of PARP maintenance, PARP inhibitors, PARP, Ovarian cancer.
- TermHomologous recombination deficiency (HRD)
Shares PRIMA / ENGOT-OV26, ARCAGY-GINECO, Base excision repair, PARP & alkylation damage, Synthetic lethality: paired dependencies.
- IdeaWhich patients' blood clones will become leukaemia after treatment?
Shares DNA damage response & homologous recombination, PARP inhibitors, PARP, Ovarian cancer.
- TargetATR
Shares Base excision repair, PARP & alkylation damage, DNA damage response & homologous recombination, Synthetic lethality: paired dependencies, Double-strand break repair: HR versus end joining.