Rucaparib
A PARP inhibitor for BRCA-mutated ovarian and prostate cancer whose original maker went bankrupt; still available, with a narrowed label.
Approved 2016 (BRCA-mutated ovarian cancer after ≥2 chemotherapies; later restricted after OS concerns in ARIEL4), 2018 as recurrent-disease maintenance (ARIEL3; later restricted to BRCA-mutated), and 2020 for BRCA-mutated mCRPC (TRITON2). ATHENA-MONO showed first-line maintenance PFS benefit in all comers. Clovis Oncology filed for bankruptcy in December 2022; pharma& now markets it.
1.Enters the cell and binds PARP1 at single-strand DNA breaks
- Route
- Oral
- Schedule
- 600 mg twice daily continuously
- Dose modifications
- Dose reductions to 500, 400, 300 mg for anaemia, nausea, ALT rise
- Monitoring
- CBC monthly; creatinine rises are usually benign (transporter inhibition)
- 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).
- 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
- 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
- Reappraised in 2023 after ARIEL3 overall survival data; check NICE for the current position.
- 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 TA611 · NHS England Cancer Drugs Fund list · SMC advice: rucaparib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 19 Dec 2016ApprovalUS
Accelerated approval, gBRCA/sBRCA ovarian, ≥2 prior lines
- 6 Apr 2018ApprovalUS
Recurrent ovarian maintenance (ARIEL3)
- Jun 2022Label changeUS
Later-line treatment indication withdrawn after ARIEL4 OS imbalance
- 11 Dec 2022WithdrawalUS
Clovis Oncology bankruptcy; asset sold to pharma&
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2016 | BRCA-mutated advanced ovarian cancer after ≥2 chemotherapies (later narrowed) |
| US | 2018 | Maintenance in recurrent ovarian cancer after platinum response (now BRCA-mutated only) |
| US | 2020 | BRCA-mutated mCRPC after ARPI and taxane |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Nausea | 75% | 4% |
| Anaemia | 37% | 19% |
| Fatigue | 69% | 7% |
ARIEL3. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Rucaparib" OR ABSTRACT:"Rucaparib" OR TITLE:"Rubraca" OR ABSTRACT:"Rubraca") 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 Rucaparib, not a curated reading list.
Pages like this
not linked directly; found by shared links- InstitutionNewcastle Cancer Centre / Northern Centre for Cancer Care
Shares Ruth Plummer, PARP inhibitors, PARP, BRCA1 / BRCA2 (HRD).
- IdeaA functional test for homologous recombination deficiency validated across laboratories
Shares Homologous recombination deficiency (HRD), PARP inhibitors, PARP, BRCA1 / BRCA2 (HRD).
- TrialSOLO-1
Shares PARP inhibitors, PARP, BRCA1 / BRCA2 (HRD), Ovarian cancer.
- PersonAlan Ashworth
Shares PARP inhibitors, PARP, BRCA1 / BRCA2 (HRD), Ovarian cancer.
- CollectionOvarian Cancer Research Alliance (OCRA)
Shares Homologous recombination deficiency (HRD), PARP inhibitors, BRCA1 / BRCA2 (HRD), Ovarian cancer.
- ProductTalazoparib
Shares Base excision repair, PARP & alkylation damage, Double-strand break repair: HR versus end joining, PARP inhibitors, PARP.
- TermGermline BRCA mutation (gBRCA)
Shares Homologous recombination deficiency (HRD), PARP inhibitors, BRCA1 / BRCA2 (HRD), Ovarian cancer.
- TechnologyHRD & BRCA testing
Shares Homologous recombination deficiency (HRD), Double-strand break repair: HR versus end joining, PARP, BRCA1 / BRCA2 (HRD).