OnCo
drugsProductApproved2016🇪🇺🇬🇧🇦🇺

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.

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Rucaparib
PubChem
Mechanism, step by step
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1.Enters the cell and binds PARP1 at single-strand DNA breaks

Modality
Small-molecule PARP inhibitor
Mechanism
PARP1/2/3 inhibitor and trapper; synthetic lethality with homologous recombination deficiency.
Brand / code
Rubraca
Dosing & schedule
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

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.

Cancer Drugs FundNICE TA611 · 2019SMC: accepted
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.

Regulatory

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  1. 19 Dec 2016ApprovalUS

    Accelerated approval, gBRCA/sBRCA ovarian, ≥2 prior lines

  2. 6 Apr 2018ApprovalUS

    Recurrent ovarian maintenance (ARIEL3)

  3. Jun 2022Label changeUS

    Later-line treatment indication withdrawn after ARIEL4 OS imbalance

  4. 11 Dec 2022WithdrawalUS

    Clovis Oncology bankruptcy; asset sold to pharma&

Approvals

RegionYearIndication
US2016BRCA-mutated advanced ovarian cancer after ≥2 chemotherapies (later narrowed)
US2018Maintenance in recurrent ovarian cancer after platinum response (now BRCA-mutated only)
US2020BRCA-mutated mCRPC after ARPI and taxane

Safety

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Toxicity profile
Adverse eventAny gradeGrade 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

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Rucaparib
intervention: Rucaparib
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend63 papers in the last 12 months-21% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query 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.

Connected

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