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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.
The current US Lynparza label separates tumour type, treatment line, biomarker and combination. Breast indications require germline BRCA: high-risk HER2-negative adjuvant treatment after chemotherapy, and HER2-negative metastatic treatment after chemotherapy with prior endocrine therapy or unsuitability in HR-positive disease. Ovarian first-line monotherapy maintenance requires germline or somatic BRCA; first-line maintenance with bevacizumab requires HRD-positive disease; recurrent maintenance requires germline or somatic BRCA. Pancreatic maintenance requires germline BRCA-mutated metastatic disease without progression after at least 16 weeks of first-line platinum. Prostate monotherapy covers germline or somatic HRR-gene-mutated mCRPC after enzalutamide or abiraterone; the abiraterone/prednisone combination is BRCA selected. The original 2014 ovarian later-line treatment indication was withdrawn, while these maintenance indications remain. Somatic-BRCA breast phase 2 activity does not create an approved adjuvant indication.
PARP1/2 inhibitor and trapper; synthetic lethality with HRD. Connects to PARP and BRCA1 / BRCA2 (HRD).
1.Olaparib binds PARP1/2 at sites of 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.
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
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. BRCA or HRD status by an approved test, depending on indication.
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 TA381 · SMC advice: olaparib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer after treatment with 3 or more lines of chemotherapy 2
gBRCA advanced ovarian cancer after ≥3 lines: first PARP inhibitor source
Deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer after treatment with 3 or more lines of chemotherapy 2
Maintenance in platinum-sensitive recurrent ovarian cancer; tablet formulation source
gBRCA HER2-negative metastatic breast cancer (OlympiAD) source
First-line maintenance in BRCA-mutated ovarian cancer (SOLO-1) source
gBRCA metastatic pancreatic cancer maintenance (POLO) source
HRR-mutant mCRPC (PROfound) source
Adjuvant gBRCA high-risk HER2-negative early breast cancer (OlympiA) source
With abiraterone in BRCA-mutated mCRPC (PROpel) source
| Region | Year | Indication |
|---|---|---|
| US | 2014 | Historical germline-BRCA advanced ovarian cancer after at least three chemotherapy lines; treatment indication withdrawn |
| US | 2017 | Recurrent ovarian maintenance after platinum response; current scope is germline or somatic BRCA-mutated |
| US | 2018 | Germline-BRCA HER2-negative metastatic breast cancer with prior chemotherapy and endocrine therapy when appropriate |
| US | 2018 | Germline or somatic BRCA-mutated advanced ovarian first-line maintenance after platinum response |
| US | 2019 | Germline-BRCA metastatic pancreatic maintenance without progression after at least 16 weeks of first-line platinum |
| US | 2020 | First-line ovarian maintenance with bevacizumab for HRD-positive disease |
| US | 2020 | Germline or somatic HRR-gene-mutated mCRPC after enzalutamide or abiraterone |
| US | 2022 | Germline-BRCA high-risk HER2-negative early breast cancer after chemotherapy |
| US | 2023 | BRCA-mutated mCRPC with abiraterone and prednisone or prednisolone |
| EU | 2019 | Germline BRCA1/2-mutated HER2-negative locally advanced or metastatic breast cancer after an anthracycline and a taxane (OlympiAD) · https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza |
| EU | 2022 | Adjuvant treatment, alone or with endocrine therapy, of germline BRCA1/2-mutated HER2-negative high-risk early breast cancer after neoadjuvant or adjuvant chemotherapy (OlympiA) · https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza |
| UK | 2023 | Adjuvant treatment of BRCA mutation-positive HER2-negative high-risk early breast cancer after chemotherapy; NICE TA886 (10 May 2023) recommends within the marketing authorisation with a commercial arrangement · https://www.nice.org.uk/guidance/ta886 |
| UK | 2025 | BRCA mutation-positive HER2-negative locally advanced or metastatic breast cancer after an anthracycline and a taxane; NICE TA1040 (12 February 2025) recommends with a commercial arrangement, the lowest-cost option to be used where talazoparib is also suitable · https://www.nice.org.uk/guidance/ta1040 |
| US | 2019 | Maintenance treatment of deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of first-line platinum-based chemotherapy (POLO), with an FDA-approved companion diagnostic · Lynparza label (openFDA), indication 1.6 and POLO study section: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22LYNPARZA%22 |
| EU | 2020 | Maintenance treatment of germline BRCA1/2-mutated metastatic pancreatic adenocarcinoma that has not progressed after at least 16 weeks of platinum-based first-line chemotherapy; listed in the EMA Lynparza product information read on 24 September 2026 (extension of indication in 2020) · https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Nausea OlympiA adjuvant, n=911 | 57% | 0.8% |
| Fatigue OlympiA adjuvant, n=911 | 42% | 1.8% |
| Anaemia OlympiA adjuvant, n=911 | 24% | 9% |
| Vomiting OlympiA adjuvant, n=911 | 23% | 0.7% |
| Diarrhoea OlympiA adjuvant, n=911 | 18% | 0.3% |
| Leukopenia OlympiA adjuvant, n=911 | 17% | 3% |
| Neutropenia OlympiA adjuvant, n=911 | 16% | 5% |
| MDS/AML Cumulative across trials; 54% fatal | 1.2% | - |
| Pneumonitis OlympiA adjuvant, n=911 | 1% | - |
| Venous thromboembolism (prostate) OlympiA adjuvant, n=911 | 8% | - |
Rates read from the US prescribing information. 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.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | astrazeneca-us.com/medicines/access-360 |
| United Kingdom | NICE: recommended in ovarian maintenance (TA598, TA620), adjuvant gBRCA breast (TA886), metastatic breast (TA1100), prostate (TA887) | not disclosed | - |
| European Union | EMA approved across indications | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Observational prescribing/safety data do not establish efficacy, comparative benefit or safety after prior pneumonitis.
Answers the two questions that hung over adjuvant olaparib, durability and late leukaemia, in its favour; the remaining question is whether carriers who also received pembrolizumab or capecitabine, whom the trial did not study, get the same benefit.
Metastatic single-arm evidence does not supply a somatic-only adjuvant indication or a personal response probability.
Durvalumab-based chemo-immunotherapy is a third first-line option with RUBY and NRG-GY018, and durvalumab plus olaparib maintenance is approved for mismatch repair-proficient disease in some regions.
For TNBC, which is diagnosed young and is the PARP inhibitor-eligible subtype, the guideline makes germline testing part of the diagnostic workup rather than a referral decision.
The survival result that moved adjuvant olaparib from a disease-free survival approval to an undisputed standard, and the reason germline testing at diagnosis of triple-negative breast cancer is now a treatment decision rather than a family history exercise.
Olaparib maintenance remains a standard option because of its progression-free benefit, tolerability and long-term survivors, but patients should know that it has not been shown to extend average survival.
Everyone with HER2-negative early breast cancer that meets high-risk criteria should be offered germline BRCA testing, because a positive result now changes treatment: a year of olaparib after chemotherapy reduces relapse and death. It does not apply to low-risk tumours, HER2-positive disease, or somatic-only BRCA mutations.
Query for this drug: (TITLE:"Olaparib" OR ABSTRACT:"Olaparib" OR TITLE:"Lynparza" OR ABSTRACT:"Lynparza") 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 Olaparib, not a curated reading list.
Shares PARP inhibitor + AR pathway inhibitor (prostate), Iniparib, Germline testing in patients with breast cancer: ASCO-Society of Surgical Oncology guideline, Inherited mutations in 17 breast cancer susceptibility genes among a large triple-negative breast cancer cohort unselected for family history of breast cancer.
Shares PARP inhibitor + bevacizumab maintenance (HRD-positive), A functional test for homologous recombination deficiency validated across laboratories, PAOLA-1 / ENGOT-ov25, Homologous recombination deficiency (HRD) in breast cancer.
Shares Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Pat, Amit M. Oza, PARP inhibitor + AR pathway inhibitor (prostate), ctDNA-guided duration of PARP maintenance.
Shares Germline testing in patients with breast cancer: ASCO-Society of Surgical Oncology guideline, Inherited mutations in 17 breast cancer susceptibility genes among a large triple-negative breast cancer cohort unselected for family history of breast cancer, Homologous recombination deficiency (HRD) in breast cancer, Metastatic Pancreatic Cancer: ASCO Guideline Update.
Shares Germline BRCA test → adjuvant PARP inhibitor, Germline testing in patients with breast cancer: ASCO-Society of Surgical Oncology guideline, Susan M. Domchek, Inherited mutations in 17 breast cancer susceptibility genes among a large triple-negative breast cancer cohort unselected for family history of breast cancer.
Shares A functional test for homologous recombination deficiency validated across laboratories, Isabelle Ray-Coquard, Homologous recombination deficiency (HRD) in breast cancer, ARCAGY-GINECO.
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 POLO: maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer, TOPARP-A: DNA-repair defects and olaparib in metastatic prostate cancer, SOLO-1: two years of olaparib maintenance after first-line chemotherapy for BRCA-mutated ovarian cancer, PAOLA-1: olaparib added to bevacizumab maintenance in newly diagnosed ovarian cancer, with benefit confined to HRD-positive tumours.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/