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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.
PARP1/2/3 inhibitor and trapper; synthetic lethality with homologous recombination deficiency. Connects to PARP and BRCA1 / BRCA2 (HRD).
1.Enters the cell and binds PARP1 at single-strand DNA breaks
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).
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 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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Deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer treated with 2 or more chemotherapies 2
Accelerated approval, gBRCA/sBRCA ovarian, ≥2 prior lines
Deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer treated with 2 or more chemotherapies 2
Recurrent ovarian maintenance (ARIEL3)
Treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source
Later-line treatment indication withdrawn after ARIEL4 OS imbalance
Clovis Oncology bankruptcy; asset sold to pharma&
Treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy
Confirmed: the accelerated approval of 2020 converted to traditional approval 5.6 years after it was granted. source
| 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.
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.
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The randomised proof for PARP inhibition in BRCA-altered prostate cancer, and the clearest evidence that the homologous recombination repair gene list should not be used as a single yes-or-no test. ATM-altered disease needs a different answer, and does not yet have one.
It is the evidence that PALB2 and somatic BRCA2 belong in the PARP inhibitor conversation even though the olaparib label stops at germline BRCA.
The trial behind the second PARP inhibitor licensed in prostate cancer, and the evidence that a somatic BRCA alteration predicts response as well as an inherited one. Together with TOPARP-A it is why tumour as well as germline sequencing is recommended in metastatic disease.
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.
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 TRITON3: rucaparib or physician's choice in metastatic castration-resistant prostate cancer, TRITON2: rucaparib in men with metastatic castration-resistant prostate cancer harbouring a BRCA1 or BRCA2 alteration, Base excision repair, PARP & alkylation damage, Test every man for DNA repair faults on the day his prostate cancer is found to have spread, not three treatments later.
Shares 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), Base excision repair, PARP & alkylation damage.
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 Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations, Homologous recombination repair gene mutation in prostate cancer, Germline BRCA1/2 pathogenic variant (gBRCAm), High-grade serous ovarian cancer.
Shares Phase II study of maintenance rucaparib in patients with platinum-sensitive advanced pancreatic cancer and a pathogenic germline or somatic variant in BRCA1, BRCA2, or PALB2, TRITON3: rucaparib or physician's choice in metastatic castration-resistant prostate cancer, Genome-wide loss of heterozygosity (gLOH), TRITON2: rucaparib in men with metastatic castration-resistant prostate cancer harbouring a BRCA1 or BRCA2 alteration.
Shares TRITON3, Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters, PARP, PARP inhibitors.
Shares TRITON3: rucaparib or physician's choice in metastatic castration-resistant prostate cancer, Test every man for DNA repair faults on the day his prostate cancer is found to have spread, not three treatments later, Homologous recombination repair gene mutation in prostate cancer, Germline BRCA1/2 pathogenic variant (gBRCAm).