{"entity":{"id":"rucaparib","kind":"drug","name":"Rucaparib","aka":[],"tldr":"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 The 2016 ovarian later-line treatment indication was withdrawn, rather than merely narrowed.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.","status":"approved","asOf":"2026-10-10","wikipedia":"https://en.wikipedia.org/wiki/Rucaparib","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Rucaparib"},{"label":"TRITON3 (New England Journal of Medicine 2023)","url":"https://doi.org/10.1056/NEJMoa2214676"},{"label":"NICE TA887: olaparib for previously treated BRCA mutation-positive hormone-relapsed metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta887"},{"label":"Current FDA Rubraca label data","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22RUBRACA%22&limit=1"},{"label":"FDA ovarian treatment withdrawal notice","url":"https://www.govinfo.gov/content/pkg/FR-2024-03-26/pdf/2024-06299.pdf"},{"label":"FDA regular approval, December 2025","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer"}],"tags":[],"related":["brca-somatic"],"cancers":["ovarian","prostate","high-grade-serous-ovarian-cancer","platinum-sensitive-ovarian-cancer","pancreatic","brca-palb2-pdac"],"sections":[],"technologies":["parp-inhibitor"],"targets":["parp","brca"],"drugs":[],"companies":["pharmaand"],"institutions":[],"pathways":[],"terms":["hrd","prostate-hrr-eligibility"],"trials":["athena-mono","nct03542175","nct01074970"],"people":[],"bottlenecks":[],"keyPapers":["paper-kalra-bre09-146-rucaparib-npj-2021","paper-reiss-rucaparib-maintenance-brca-palb2-pancreatic-jco-2021"],"journals":[],"dependsOn":[],"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."],"brand":"Rubraca","modality":"Small-molecule PARP inhibitor","mechanism":"PARP1/2/3 inhibitor and trapper; synthetic lethality with homologous recombination deficiency.","approvals":[{"region":"US","year":2016,"indication":"BRCA-mutated advanced ovarian cancer after at least two chemotherapies; this treatment indication was withdrawn"},{"region":"US","year":2018,"indication":"Recurrent ovarian, fallopian-tube or primary-peritoneal maintenance after platinum response; current scope is germline or somatic BRCA-mutated"},{"region":"US","year":2020,"indication":"Historical accelerated BRCA-mutated mCRPC approval after ARPI and taxane; replaced by regular approval in 2025"},{"region":"US","year":2025,"indication":"Regular approval, germline or somatic BRCA-mutated mCRPC after androgen receptor-directed therapy"}],"mechanismSteps":["Enters the cell and binds PARP1 at single-strand DNA breaks","Traps PARP on DNA, blocking base-excision repair","Replication forks collapse into double-strand breaks","BRCA-deficient cells cannot repair them and die"],"dosing":{"route":"Oral","schedule":"600 mg twice daily continuously","modifications":"Dose reductions to 500, 400, 300 mg for anaemia, nausea, ALT rise","monitoring":"CBC monthly; creatinine rises are usually benign (transporter inhibition)"},"toxicity":[{"event":"Nausea","anyGradePct":75,"grade3PlusPct":4,"note":"ARIEL3"},{"event":"Anaemia","anyGradePct":37,"grade3PlusPct":19},{"event":"Fatigue","anyGradePct":69,"grade3PlusPct":7}],"access":[],"regulatoryEvents":[{"date":"2016-12-19","type":"accelerated-approval","region":"US","note":"Accelerated approval, gBRCA/sBRCA ovarian, ≥2 prior lines","indication":"Deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer treated with 2 or more chemotherapies 2"},{"date":"2018-04-06","type":"conversion","region":"US","note":"Recurrent ovarian maintenance (ARIEL3)","indication":"Deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer treated with 2 or more chemotherapies 2"},{"date":"2020-05-15","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel","indication":"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"},{"date":"2024-03-26","type":"withdrawal","region":"US","note":"FDA formally withdrew the later-line advanced ovarian treatment indication; other approved indications unaffected","source":"https://www.govinfo.gov/content/pkg/FR-2024-03-26/pdf/2024-06299.pdf"},{"date":"2025-12-17","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2020 converted to traditional approval 5.6 years after it was granted.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel","indication":"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"},{"date":"2025-12-17","type":"approval","region":"US","note":"Regular approval for deleterious germline or somatic BRCA-mutated mCRPC after androgen receptor-directed therapy; no prior-taxane requirement in this indication","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer"}]},"route":"/drugs/rucaparib/","neighbours":{"biomarker":[{"id":"brca-germline","kind":"biomarker","name":"Germline BRCA1/2 pathogenic variant (gBRCAm)","route":"/biomarkers/brca-germline/"},{"id":"hrr-gene-mutation","kind":"biomarker","name":"Homologous recombination repair gene mutation in prostate cancer","route":"/biomarkers/hrr-gene-mutation/"},{"id":"brca-somatic","kind":"biomarker","name":"Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations","route":"/biomarkers/brca-somatic/"}],"cancer":[{"id":"brca-palb2-pdac","kind":"cancer","name":"BRCA or PALB2-mutant pancreatic ductal adenocarcinoma","route":"/cancers/brca-palb2-pdac/"},{"id":"high-grade-serous-ovarian-cancer","kind":"cancer","name":"High-grade serous ovarian cancer","route":"/cancers/high-grade-serous-ovarian-cancer/"},{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"platinum-sensitive-ovarian-cancer","kind":"cancer","name":"Platinum-sensitive ovarian cancer","route":"/cancers/platinum-sensitive-ovarian-cancer/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"parp-inhibitor","kind":"technology","name":"PARP inhibitors","route":"/technologies/parp-inhibitor/"},{"id":"rad51-foci-assay","kind":"technology","name":"RAD51 foci assay (functional HRD test)","route":"/technologies/rad51-foci-assay/"}],"target":[{"id":"brca","kind":"target","name":"BRCA1 / BRCA2 (HRD)","route":"/targets/brca/"},{"id":"parp","kind":"target","name":"PARP","route":"/targets/parp/"}],"company":[{"id":"clovis-oncology","kind":"company","name":"Clovis Oncology","route":"/companies/clovis-oncology/"},{"id":"pharmaand","kind":"company","name":"pharma&","route":"/companies/pharmaand/"}],"term":[{"id":"brca-reversion-mutations","kind":"term","name":"BRCA reversion mutations","route":"/terms/brca-reversion-mutations/"},{"id":"genome-wide-loss-of-heterozygosity","kind":"term","name":"Genome-wide loss of heterozygosity (gLOH)","route":"/terms/genome-wide-loss-of-heterozygosity/"},{"id":"hrd","kind":"term","name":"Homologous recombination deficiency (HRD)","route":"/terms/hrd/"},{"id":"prostate-hrr-eligibility","kind":"term","name":"Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters","route":"/terms/prostate-hrr-eligibility/"}],"trial":[{"id":"athena-mono","kind":"trial","name":"ATHENA-MONO / GOG-3020","route":"/trials/athena-mono/"},{"id":"nct01074970","kind":"trial","name":"BRE09-146: postoperative cisplatin with or without rucaparib","route":"/trials/nct01074970/"},{"id":"nct03542175","kind":"trial","name":"Rucaparib with radiation after incomplete response to chemotherapy","route":"/trials/nct03542175/"},{"id":"triton3","kind":"trial","name":"TRITON3","route":"/trials/triton3/"}],"paper":[{"id":"paper-kalra-bre09-146-rucaparib-npj-2021","kind":"paper","name":"BRE09-146: cisplatin with or without rucaparib after preoperative breast chemotherapy","route":"/key-papers/paper-kalra-bre09-146-rucaparib-npj-2021/"},{"id":"paper-reiss-rucaparib-maintenance-brca-palb2-pancreatic-jco-2021","kind":"paper","name":"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","route":"/key-papers/paper-reiss-rucaparib-maintenance-brca-palb2-pancreatic-jco-2021/"},{"id":"paper-abida-triton2-rucaparib-brca-jco-2020","kind":"paper","name":"TRITON2: rucaparib in men with metastatic castration-resistant prostate cancer harbouring a BRCA1 or BRCA2 alteration","route":"/key-papers/paper-abida-triton2-rucaparib-brca-jco-2020/"},{"id":"paper-fizazi-triton3-rucaparib-nejm-2023","kind":"paper","name":"TRITON3: rucaparib or physician's choice in metastatic castration-resistant prostate cancer","route":"/key-papers/paper-fizazi-triton3-rucaparib-nejm-2023/"}],"idea":[{"id":"idea-prostate-hrr-testing-at-metastatic-diagnosis","kind":"idea","name":"Test every man for DNA repair faults on the day his prostate cancer is found to have spread, not three treatments later","route":"/ideas/idea-prostate-hrr-testing-at-metastatic-diagnosis/"}],"person":[{"id":"ruth-plummer","kind":"person","name":"Ruth Plummer","route":"/people/ruth-plummer/"}],"pathway":[{"id":"base-excision-repair-parp","kind":"pathway","name":"Base excision repair, PARP & alkylation damage","route":"/pathways/base-excision-repair-parp/"},{"id":"homologous-recombination-repair","kind":"pathway","name":"Double-strand break repair: HR versus end joining","route":"/pathways/homologous-recombination-repair/"}]}}