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.
Overview
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.
- FoundationOne CDx · Per companion claim: EGFR, ALK, BRAF V600, ERBB2 amplification, KRAS wild-type, BRCA1/2 and HRR genes, PIK3CA, MET exon 14, RET, FGFR2 fusions, IDH1, NTRK fusions; MSI-high; TMB at least 10 mutations per megabase
- FoundationOne Liquid CDx · Per companion claim: EGFR (osimertinib, erlotinib, gefitinib), ALK (alectinib), BRCA1/2 and ATM (olaparib, rucaparib), PIK3CA (alpelisib), FGFR3 (erdafitinib), NTRK and RET; negative plasma results reflex to tissue
- BRACAnalysis CDx · Deleterious or suspected deleterious germline variant
- myChoice CDx · Genomic instability score at least 42, or BRCA1/2 mutation, defines HRD-positive (olaparib plus bevacizumab, PAOLA-1; niraparib)
- 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). With abiraterone for untreated hormone-relapsed metastatic prostate cancer when docetaxel is unsuitable (PROpel): TA951 (February 2024), within the licence. Germline BRCA-mutated HER2-negative advanced breast cancer after anthracycline and taxane (OlympiAD): TA1040 (February 2025), within the licence. Previously treated BRCA-mutated hormone-relapsed metastatic prostate cancer was first appraised as TA831 (October 2022).
- 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.
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- 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
Latest papers
topQuery for this drug: (TITLE:"Olaparib" OR ABSTRACT:"Olaparib" OR TITLE:"Lynparza" OR ABSTRACT:"Lynparza") AND (radiopharmaceutical OR radioligand OR radionuclide OR theranostic OR "nuclear medicine" OR "molecular imaging" OR radiotracer OR scintigraphy OR 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.
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