{"entity":{"id":"olaparib","kind":"drug","name":"Olaparib","aka":[],"tldr":"Olaparib was the first PARP inhibitor, and turned an inherited BRCA mutation from a risk factor into a drug target, including after surgery in breast cancer.","summary":"Approved 2014 (ovarian), then maintenance first-line (SOLO-1, 7-year OS benefit), with bevacizumab (PAOLA-1, HRD+), metastatic BRCA breast (OlympiAD), adjuvant germline-BRCA HER2-negative early breast cancer (OlympiA, OS HR 0.72), pancreatic maintenance (POLO), and prostate (PROfound; PROpel with abiraterone). AstraZeneca/Merck.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Olaparib","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Olaparib"}],"tags":[],"related":[],"indications":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":["parp"],"drugs":[],"companies":["astrazeneca","merck"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06909825"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Lynparza","modality":"Small-molecule PARP inhibitor","mechanism":"PARP1/2 inhibitor and trapper; synthetic lethality with HRD.","approvals":[{"region":"US","year":2014,"indication":"gBRCA ovarian cancer ≥3 lines"},{"region":"US","year":2018,"indication":"gBRCA HER2- metastatic breast cancer"},{"region":"US","year":2022,"indication":"Adjuvant gBRCA high-risk HER2- early breast cancer"}],"mechanismSteps":["Olaparib binds PARP1/2 at sites of single-strand DNA breaks","PARP is trapped on DNA and repair of single-strand breaks stops","Replication forks collide with trapped PARP and collapse into double-strand breaks","BRCA-deficient cells cannot repair the breaks by homologous recombination","Genomic catastrophe and apoptosis in tumour cells; normal cells with intact BRCA survive"],"dosing":{"route":"Oral","schedule":"300 mg twice daily; 1 year adjuvant (OlympiA); 2 years first-line ovarian maintenance; until progression otherwise","modifications":"200 mg BID for moderate renal impairment; hold for grade ≥3 anaemia; discontinue for MDS/AML or pneumonitis","monitoring":"Blood counts monthly; respiratory symptoms; embryo-fetal counselling","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa"},"toxicity":[{"event":"Nausea","anyGradePct":57,"grade3PlusPct":0.8,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa","note":"OlympiA adjuvant, n=911"},{"event":"Fatigue","anyGradePct":42,"grade3PlusPct":1.8,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa","note":"OlympiA adjuvant, n=911"},{"event":"Anaemia","anyGradePct":24,"grade3PlusPct":9,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa","note":"OlympiA adjuvant, n=911"},{"event":"Vomiting","anyGradePct":23,"grade3PlusPct":0.7,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa","note":"OlympiA adjuvant, n=911"},{"event":"Diarrhoea","anyGradePct":18,"grade3PlusPct":0.3,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa","note":"OlympiA adjuvant, n=911"},{"event":"Leukopenia","anyGradePct":17,"grade3PlusPct":3,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa","note":"OlympiA adjuvant, n=911"},{"event":"Neutropenia","anyGradePct":16,"grade3PlusPct":5,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa","note":"OlympiA adjuvant, n=911"},{"event":"MDS/AML","anyGradePct":1.2,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa","note":"Cumulative across trials; 54% fatal"},{"event":"Pneumonitis","anyGradePct":1,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa","note":"OlympiA adjuvant, n=911"},{"event":"Venous thromboembolism (prostate)","anyGradePct":8,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa","note":"OlympiA adjuvant, n=911"}],"access":[{"country":"US","reimbursement":"Medicare Part D (oral); commercial plans per formulary, often with prior authorisation","assistance":"https://www.astrazeneca-us.com/medicines/access-360","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended in ovarian maintenance (TA598, TA620), adjuvant gBRCA breast (TA886), metastatic breast (TA1100), prostate (TA887)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"},{"country":"EU","reimbursement":"EMA approved across indications","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2014-12-19","type":"approval","region":"US","note":"gBRCA advanced ovarian cancer after ≥3 lines: first PARP inhibitor","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2017-08-17","type":"approval","region":"US","note":"Maintenance in platinum-sensitive recurrent ovarian cancer; tablet formulation","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2018-01-12","type":"approval","region":"US","note":"gBRCA HER2-negative metastatic breast cancer (OlympiAD)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2018-12-19","type":"approval","region":"US","note":"First-line maintenance in BRCA-mutated ovarian cancer (SOLO-1)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2019-12-27","type":"approval","region":"US","note":"gBRCA metastatic pancreatic cancer maintenance (POLO)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2020-05-19","type":"approval","region":"US","note":"HRR-mutant mCRPC (PROfound)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2022-03-11","type":"approval","region":"US","note":"Adjuvant gBRCA high-risk HER2-negative early breast cancer (OlympiA)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2023-05-31","type":"approval","region":"US","note":"With abiraterone in BRCA-mutated mCRPC (PROpel)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/olaparib/","neighbours":{"indication":[{"id":"prostate-mcrpc","kind":"indication","name":"Metastatic castration-resistant prostate cancer","route":"/indications/prostate-mcrpc/"},{"id":"prostate","kind":"indication","name":"Prostate cancer","route":"/indications/prostate/"}],"target":[{"id":"parp","kind":"target","name":"PARP","route":"/targets/parp/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"},{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"trial":[{"id":"nct06909825","kind":"trial","name":"FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","route":"/trials/nct06909825/"}],"institution":[{"id":"royal-marsden","kind":"institution","name":"The Royal Marsden","route":"/institutions/royal-marsden/"}],"pathway":[{"id":"prostate-cancer-signalling","kind":"pathway","name":"Prostate cancer (KEGG map)","route":"/pathways/prostate-cancer-signalling/"}],"idea":[{"id":"idea-rlt-plus-parp-inhibitor","kind":"idea","name":"Adding a PARP inhibitor to PSMA radioligand therapy","route":"/ideas/idea-rlt-plus-parp-inhibitor/"}],"pairing":[{"id":"pluvicto-plus-olaparib","kind":"pairing","name":"177Lu-PSMA-617 (Pluvicto) with olaparib","route":"/pairings/pluvicto-plus-olaparib/"}]}}