# Rucaparib

Source: https://onco.cc/drugs/rucaparib/  
OnCo record `rucaparib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Rucaparib is a DNA-repair inhibitor for selected BRCA-mutated ovarian and prostate cancers. Its prostate indication received regular US approval in December 2025.

## Summary

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 The 2016 ovarian later-line treatment indication was withdrawn, rather than merely narrowed.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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-10-10
- Brand: Rubraca
- Modality: Small-molecule PARP inhibitor
- Mechanism: PARP1/2/3 inhibitor and trapper; synthetic lethality with homologous recombination deficiency.
- Approvals: US 2016: BRCA-mutated advanced ovarian cancer after at least two chemotherapies; this treatment indication was withdrawn; US 2018: Recurrent ovarian, fallopian-tube or primary-peritoneal maintenance after platinum response; current scope is germline or somatic BRCA-mutated; US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
- Dosing: Oral; 600 mg twice daily continuously
- Toxicity (grade 3+): Nausea 4%; Anaemia 19%; Fatigue 7%

## Notes

- Pancreatic ductal adenocarcinoma: a single-arm phase 2 of maintenance rucaparib in platinum-sensitive patients with germline or somatic BRCA1, BRCA2 or PALB2 variants gave 6-month progression-free survival of 59.5% and a 41.7% response rate, including responses in germline PALB2 and somatic BRCA2; there is no pancreatic approval (Reiss 2021).
- TRITON3 is the trial that defines who rucaparib helps in prostate cancer, and it is a gene-specific answer: imaging-based progression-free survival 11.2 against 6.4 months in the BRCA subgroup (hazard ratio 0.50, 95 percent confidence interval 0.36 to 0.69) and 8.1 against 6.8 months in the ATM subgroup (0.95, 0.59 to 1.52). There is no NICE appraisal of rucaparib in prostate cancer; in England the PARP inhibitor route for BRCA-mutated hormone-relapsed disease is olaparib under TA887.

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Rucaparib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Rucaparib
- TRITON3 (New England Journal of Medicine 2023): https://doi.org/10.1056/NEJMoa2214676
- NICE TA887: olaparib for previously treated BRCA mutation-positive hormone-relapsed metastatic prostate cancer: https://www.nice.org.uk/guidance/ta887
- Current FDA Rubraca label data: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22RUBRACA%22&limit=1
- FDA ovarian treatment withdrawal notice: https://www.govinfo.gov/content/pkg/FR-2024-03-26/pdf/2024-06299.pdf
- FDA regular approval, December 2025: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer

## Connected records

- biomarkers: [Germline BRCA1/2 pathogenic variant (gBRCAm)](https://onco.cc/biomarkers/brca-germline/), [Homologous recombination repair gene mutation in prostate cancer](https://onco.cc/biomarkers/hrr-gene-mutation/), [Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations](https://onco.cc/biomarkers/brca-somatic/)
- cancers: [BRCA or PALB2-mutant pancreatic ductal adenocarcinoma](https://onco.cc/cancers/brca-palb2-pdac/), [High-grade serous ovarian cancer](https://onco.cc/cancers/high-grade-serous-ovarian-cancer/), [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Platinum-sensitive ovarian cancer](https://onco.cc/cancers/platinum-sensitive-ovarian-cancer/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [PARP inhibitors](https://onco.cc/technologies/parp-inhibitor/), [RAD51 foci assay (functional HRD test)](https://onco.cc/technologies/rad51-foci-assay/)
- targets: [BRCA1 / BRCA2 (HRD)](https://onco.cc/targets/brca/), [PARP](https://onco.cc/targets/parp/)
- companies: [Clovis Oncology](https://onco.cc/companies/clovis-oncology/), [pharma&](https://onco.cc/companies/pharmaand/)
- terms: [BRCA reversion mutations](https://onco.cc/terms/brca-reversion-mutations/), [Genome-wide loss of heterozygosity (gLOH)](https://onco.cc/terms/genome-wide-loss-of-heterozygosity/), [Homologous recombination deficiency (HRD)](https://onco.cc/terms/hrd/), [Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters](https://onco.cc/terms/prostate-hrr-eligibility/)
- trials: [ATHENA-MONO / GOG-3020](https://onco.cc/trials/athena-mono/), [BRE09-146: postoperative cisplatin with or without rucaparib](https://onco.cc/trials/nct01074970/), [Rucaparib with radiation after incomplete response to chemotherapy](https://onco.cc/trials/nct03542175/), [TRITON3](https://onco.cc/trials/triton3/)
- key papers: [BRE09-146: cisplatin with or without rucaparib after preoperative breast chemotherapy](https://onco.cc/key-papers/paper-kalra-bre09-146-rucaparib-npj-2021/), [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](https://onco.cc/key-papers/paper-reiss-rucaparib-maintenance-brca-palb2-pancreatic-jco-2021/), [TRITON2: rucaparib in men with metastatic castration-resistant prostate cancer harbouring a BRCA1 or BRCA2 alteration](https://onco.cc/key-papers/paper-abida-triton2-rucaparib-brca-jco-2020/), [TRITON3: rucaparib or physician's choice in metastatic castration-resistant prostate cancer](https://onco.cc/key-papers/paper-fizazi-triton3-rucaparib-nejm-2023/)
- ideas: [Test every man for DNA repair faults on the day his prostate cancer is found to have spread, not three treatments later](https://onco.cc/ideas/idea-prostate-hrr-testing-at-metastatic-diagnosis/)
- people: [Ruth Plummer](https://onco.cc/people/ruth-plummer/)
- pathways: [Base excision repair, PARP & alkylation damage](https://onco.cc/pathways/base-excision-repair-parp/), [Double-strand break repair: HR versus end joining](https://onco.cc/pathways/homologous-recombination-repair/)

---
JSON: https://onco.cc/api/v1/entities/rucaparib.json