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Rucaparib is a DNA-repair inhibitor for selected BRCA-mutated ovarian and prostate cancers. Its prostate indication received regular US approval in December 2025.
The current US Rubraca label covers maintenance of deleterious germline or somatic BRCA-mutated recurrent ovarian, fallopian-tube or primary-peritoneal cancer after complete or partial response to platinum, and deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer after androgen receptor-directed therapy. FDA converted the prostate indication to regular approval in December 2025 on TRITON3; the current indication does not require prior taxane chemotherapy. The 2016 ovarian later-line treatment indication was withdrawn, rather than merely narrowed. The 2018 maintenance population was subsequently restricted to BRCA-mutated disease. First-line ATHENA-MONO efficacy results do not establish a US first-line maintenance indication. Clovis bankruptcy and the subsequent asset sale are business events, not FDA withdrawal of the entire product.
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
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.
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
FDA formally withdrew the later-line advanced ovarian treatment indication; other approved indications unaffected source
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
Regular approval for deleterious germline or somatic BRCA-mutated mCRPC after androgen receptor-directed therapy; no prior-taxane requirement in this indication source
| Region | Year | Indication |
|---|---|---|
| US | 2016 | BRCA-mutated advanced ovarian cancer after at least two chemotherapies; this treatment indication was withdrawn |
| US | 2018 | Recurrent ovarian, fallopian-tube or primary-peritoneal maintenance after platinum response; current scope is germline or somatic BRCA-mutated |
| US | 2020 | Historical accelerated BRCA-mutated mCRPC approval after ARPI and taxane; replaced by regular approval in 2025 |
| US | 2025 | Regular approval, germline or somatic BRCA-mutated mCRPC after androgen receptor-directed therapy |
| 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.
Negative result for the tested low-exposure combination; not proof that every rucaparib or PARP strategy fails.
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, BRCA reversion mutations, RAD51 foci assay (functional HRD test), Genome-wide loss of heterozygosity (gLOH).
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 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: 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).
Shares TRITON3, Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters, PARP inhibitors, PARP.
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