Olaparib
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.
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.
1.Olaparib binds PARP1/2 at sites of single-strand DNA breaks
- Route
- Oral
- Schedule
- 300 mg twice daily; 1 year adjuvant (OlympiA); 2 years first-line ovarian maintenance; until progression otherwise
- Dose 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: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- AstraZeneca Access 360
- AZ&Me Prescription Savings
- Merck Access Program
- Merck Patient Assistance Program — Free medicine for eligible uninsured or underinsured patients.
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Appraised for
- Maintenance for relapsed platinum-sensitive BRCA-mutated ovarian cancer
- Notes
- First-line ovarian maintenance TA598 (2019, CDF); adjuvant BRCA-mutated HER2-negative early breast cancer TA886 (2023); BRCA-mutated mCRPC TA887 (2023).
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA381 · SMC advice: olaparib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 19 Dec 2014ApprovalUS
gBRCA advanced ovarian cancer after ≥3 lines: first PARP inhibitor source
- 17 Aug 2017ApprovalUS
Maintenance in platinum-sensitive recurrent ovarian cancer; tablet formulation source
- 12 Jan 2018ApprovalUS
gBRCA HER2-negative metastatic breast cancer (OlympiAD) source
- 19 Dec 2018ApprovalUS
First-line maintenance in BRCA-mutated ovarian cancer (SOLO-1) source
- 27 Dec 2019ApprovalUS
gBRCA metastatic pancreatic cancer maintenance (POLO) source
- 19 May 2020ApprovalUS
HRR-mutant mCRPC (PROfound) source
- 11 Mar 2022ApprovalUS
Adjuvant gBRCA high-risk HER2-negative early breast cancer (OlympiA) source
- 31 May 2023ApprovalUS
With abiraterone in BRCA-mutated mCRPC (PROpel) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2014 | gBRCA ovarian cancer ≥3 lines |
| US | 2018 | gBRCA HER2- metastatic breast cancer |
| US | 2022 | Adjuvant gBRCA high-risk HER2- early breast cancer |
| 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.
| 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.
Trials
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Landmark trials in OnCo
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.
Women with newly diagnosed advanced ovarian cancer should have their tumour tested for BRCA mutations and homologous recombination deficiency, because those who are HRD-positive gain years of additional disease control and better survival from adding olaparib to bevacizumab maintenance. Those who are HRD-negative gain nothing from olaparib in this combination and should not be exposed to its toxicity and cost. HRD testing has become a routine part of ovarian cancer care as a result.
Every woman diagnosed with advanced high-grade ovarian cancer should be tested for BRCA mutations at diagnosis, because those who carry one should receive two years of olaparib after chemotherapy, which greatly extends the time in remission and improves long-term survival. The plateau in the survival curves suggests some patients are cured by this approach. Toxicity is mostly anaemia, fatigue and nausea, and the two-year limit appears sufficient.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductNiraparib
Shares Amit M. Oza, PARP inhibitor + AR pathway inhibitor (prostate), ctDNA-guided duration of PARP maintenance, Maintenance therapy.
- TermHomologous recombination deficiency (HRD)
Shares PARP inhibitor + bevacizumab maintenance (HRD-positive), A functional test for homologous recombination deficiency validated across laboratories, PAOLA-1 / ENGOT-ov25, Germline BRCA mutation (gBRCA).
- ProductTalazoparib
Shares PARP inhibitor + AR pathway inhibitor (prostate), Iniparib, Base excision repair, PARP & alkylation damage, Androgen receptor signalling.
- TechnologyHRD & BRCA testing
Shares A functional test for homologous recombination deficiency validated across laboratories, ARCAGY-GINECO, PAOLA-1: olaparib added to bevacizumab maintenance in newly diagnosed ovarian cancer, with benefit confined to HRD-positive tumours, Mutagenesis & mutational signatures.
- TermSynthetic lethality
Shares 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, Base excision repair, PARP & alkylation damage, OlympiA: a year of olaparib after surgery for BRCA-mutated, high-risk early breast cancer.
- TechnologySynthetic lethality approaches
Shares Alan Ashworth, 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, OlympiA: a year of olaparib after surgery for BRCA-mutated, high-risk early breast cancer.
- ProductAbiraterone acetate
Shares PROpel, Centre hospitalier de l'Université de Montréal (CHUM), Johann de Bono, Androgen receptor signalling.
- TechnologyGermline (hereditary) testing
Shares POLO, Germline BRCA test → adjuvant PARP inhibitor, Susan M. Domchek, Germline BRCA mutation (gBRCA).