Key points
- Olaparib (Lynparza) is a targeted tablet that switches off DNA repair in cancer cells; it works best in tumours with a BRCA mutation or similar changes [1].
- It is used for ovarian, breast, pancreatic and prostate cancer, but only when a gene test shows that the patient or the tumour has these changes [1] (BRCA gene testing).
- 300 mg twice a day, with or without food [1].
- In women with an inherited BRCA mutation, one year of olaparib after treatment for early breast cancer reduced recurrences and deaths [1, 2].
- The most common side effects: nausea, tiredness, anaemia and vomiting; rarely, bone marrow disease or leukaemia [1].
What is this drug and how does it work?
For physicians
Olaparib (brand name Lynparza) is an oral targeted drug from the group of PARP inhibitors [1]. PARP enzymes are involved in normal cellular functions such as DNA repair. Cells that have lost homologous recombination repair (HRR) because of mutations in genes such as BRCA1, BRCA2 or ATM are much more sensitive to PARP inhibition [1].
According to the FDA label, the cytotoxicity of olaparib probably comes from inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes, leading to DNA damage and cancer cell death [1]. In prostate cancer models, PARP1 is involved in regulating androgen receptor activity, and olaparib combined with androgen receptor inhibition showed antitumour activity [1].
Which cancers is it used for?
According to the FDA label, olaparib is approved for adults with ovarian cancer (and fallopian tube or primary peritoneal cancer), HER2-negative breast cancer, metastatic pancreatic cancer and metastatic castration-resistant prostate cancer [1]. In all these uses, patients are selected with an approved test (germline or somatic BRCA mutation, mutation in other HRR genes or HRD positivity, depending on the indication) [1]. So not every patient with these cancers is a candidate for this drug, and approved indications may differ between countries.
Your doctor may prescribe this drug for:
- Advanced ovarian cancer (first line) [1, 3]
- HRD-positive advanced ovarian cancer (first line) [1, 4]
- Ovarian cancer that has come back [1, 5]
- High-risk early HER2-negative breast cancer [1, 2]
- HER2-negative breast cancer that has spread [1, 6]
- Pancreatic adenocarcinoma that has spread [1, 7]
- Prostate cancer that has spread and no longer responds to hormone therapy (mCRPC) [1, 8]
- Prostate cancer that has spread and no longer responds to hormone therapy, with a BRCA mutation [1, 9]
Whether it suits you depends on the type and stage of your cancer and your test results. Details of each use are in the section for doctors.
For physicians
| Cancer | Conditions of use | Key evidence |
|---|---|---|
| Advanced ovarian cancer (first line) | Single-agent maintenance with a germline or somatic BRCA mutation, after complete or partial response to platinum-based chemotherapy [1] | SOLO-1 trial [3]; hazard ratio for progression or death 0.30 compared with placebo (median progression-free survival not reached with olaparib vs 13.8 months) [1] |
| HRD-positive advanced ovarian cancer (first line) | Maintenance with bevacizumab, after complete or partial response to platinum-based chemotherapy; HRD-positive means a BRCA mutation and/or genomic instability [1] | PAOLA-1 trial [4]; in the HRD-positive group, median progression-free survival 37.2 vs 17.7 months and median overall survival 75.2 vs 57.3 months compared with placebo and bevacizumab [1] |
| Recurrent ovarian cancer | Maintenance with a germline or somatic BRCA mutation, after complete or partial response to platinum-based chemotherapy [1] | SOLO-2 trial [5]; median progression-free survival 19.1 vs 5.5 months with placebo [1] |
| High-risk early HER2-negative breast cancer | Adjuvant treatment for 1 year with a germline BRCA mutation, after neoadjuvant or adjuvant chemotherapy [1] | OlympiA trial [2]; hazard ratio for invasive disease-free survival 0.58 and for death 0.68 compared with placebo [1] |
| Metastatic HER2-negative breast cancer | Germline BRCA mutation, after chemotherapy; in hormone receptor-positive disease after endocrine therapy or when it is unsuitable [1] | OlympiAD trial [6]; median progression-free survival 7.0 vs 4.2 months compared with physician's choice chemotherapy [1] |
| Metastatic pancreatic adenocarcinoma | First-line maintenance with a germline BRCA mutation when the disease has not progressed during at least 16 weeks of platinum-based chemotherapy [1] | POLO trial [7]; median progression-free survival 7.4 vs 3.8 months with placebo; the overall survival difference was not significant [1] |
| Metastatic castration-resistant prostate cancer (mCRPC) | Monotherapy with HRR gene mutations (germline or somatic) after progression on enzalutamide or abiraterone [1] | PROfound trial [8]; in cohort A (BRCA1, BRCA2 or ATM mutation) median radiographic progression-free survival 7.4 vs 3.6 months and median overall survival 19.1 vs 14.7 months [1] |
| Metastatic castration-resistant prostate cancer with a BRCA mutation | With abiraterone and prednisone or prednisolone [1] | PROpel trial [9]; in patients with a BRCA mutation, hazard ratio for radiographic progression 0.24 and for death 0.30 compared with placebo and abiraterone [1] |
In prostate cancer, patients should receive a GnRH analogue at the same time or have had bilateral orchiectomy [1].
How it is taken and dosing
Show detailsHide
Treatment regimens and doses: index8 regimens
Olaparib comes as tablets (150 and 100 mg) taken twice a day, about 12 hours apart, with or without food [1]. Swallow the tablets whole; do not chew, crush, dissolve or split them [1].
How long treatment lasts depends on the disease [1]:
- First-line maintenance in ovarian cancer (alone or with bevacizumab): up to 2 years; if there is a complete response after 2 years treatment stops, and if disease remains your doctor may judge that continuing is helpful.
- Adjuvant treatment of early breast cancer: 1 year in total; in hormone receptor-positive disease, hormone therapy continues at the same time.
- Other uses: until the disease progresses or side effects cannot be tolerated.
Tests:
- Before starting, a genetic or tumour test (BRCA, HRR genes or HRD) depending on the cancer [1].
- A full blood count before starting and then monthly; treatment does not start until blood side effects of previous chemotherapy have recovered (grade 1 or less) [1].
- Liver tests (bilirubin and transaminases) before starting and during treatment [1].
- A pregnancy test before starting in women who could become pregnant [1].
- Before starting: biomarker testing with an approved companion diagnostic depending on the indication (BRCA in tumour or blood; HRD in tumour; HRR genes in tumour, blood or ctDNA in prostate cancer). Baseline CBC; start only after recovery from haematological toxicity of previous chemotherapy to grade 1 or less. Bilirubin and transaminases; pregnancy test [1].
- Administration: tablets whole (not chewed, crushed, dissolved or split) [1].
- Dose reduction for toxicity: first interrupt or reduce to 250 mg twice daily, then 200 mg twice daily [1]. Prolonged haematological toxicity: interrupt and check CBC weekly; if not recovered to grade 1 or less after 4 weeks, refer to a haematologist (bone marrow and cytogenetics); confirmed MDS/AML: discontinue. New respiratory symptoms: interrupt and investigate; confirmed pneumonitis: discontinue. Suspected drug-induced liver injury: interrupt; confirmed: discontinue [1].
- Interactions: avoid strong or moderate CYP3A inhibitors; if unavoidable: strong inhibitor 100 mg and moderate inhibitor 150 mg twice daily; return to the previous dose 3 to 5 half-lives after stopping the inhibitor. Avoid strong or moderate CYP3A inducers [1].
- Kidney and liver: moderate renal impairment (creatinine clearance 31 to 50 mL/min): 200 mg twice daily; mild (51 to 80): no adjustment; 30 or less: no data. Mild and moderate hepatic impairment (Child-Pugh A and B): no adjustment; Child-Pugh C: no data [1].
- Monitoring: monthly CBC; liver tests during treatment; signs of venous thrombosis and pulmonary embolism (especially in prostate cancer) [1].
For physicians
Standard dosing (FDA label)
First-line maintenance in BRCA-mutated advanced ovarian cancer (SOLO-1)
Ovarian, fallopian tube or primary peritoneal cancer; complete or partial response to first-line platinum chemotherapy; germline or somatic BRCACycle length: Continuous
Ovarian, fallopian tube or primary peritoneal cancer; complete or partial response to first-line platinum chemotherapy; germline or somatic BRCA [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Olaparib | 300 mg | Oral (with or without food) | Twice daily (about every 12 hours) |
Evidence: SOLO1/GOG 3004 (2023)
First-line maintenance in HRD-positive advanced ovarian cancer, with bevacizumab (PAOLA-1)
Complete or partial response to first-line platinum chemotherapy; HRD-positive (BRCA mutation and/or genomic instability)
Complete or partial response to first-line platinum chemotherapy; HRD-positive (BRCA mutation and/or genomic instability) [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Olaparib | 300 mg | Oral (with or without food) | Twice daily (about every 12 hours) |
| Every 3 weeks | |||
| Bevacizumab | 15 mg/kg | IV | Every 3 weeks |
Evidence: PAOLA-1/ENGOT-ov25 (2023)
Maintenance in BRCA-mutated recurrent ovarian cancer (SOLO-2)
Complete or partial response to platinum chemotherapy; germline or somatic BRCACycle length: Continuous
Complete or partial response to platinum chemotherapy; germline or somatic BRCA [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Olaparib | 300 mg | Oral (with or without food) | Twice daily (about every 12 hours) |
Evidence: SOLO2/ENGOT-Ov21 (2017)
Adjuvant treatment of high-risk early HER2-negative breast cancer with a germline BRCA mutation (OlympiA)
After neoadjuvant or adjuvant chemotherapyCycle length: Continuous
After neoadjuvant or adjuvant chemotherapy [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Olaparib | 300 mg | Oral (with or without food) | Twice daily (about every 12 hours) |
In hormone receptor-positive disease, continue concurrent endocrine therapy as per guidelines [1].
Evidence: OlympiA (2026), OlympiA (2021)
Metastatic HER2-negative breast cancer with a germline BRCA mutation (OlympiAD)
After chemotherapy; in HR-positive disease after endocrine therapy or if unsuitable for itCycle length: Continuous
After chemotherapy; in HR-positive disease after endocrine therapy or if unsuitable for it [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Olaparib | 300 mg | Oral (with or without food) | Twice daily (about every 12 hours) |
Evidence: OlympiAD (2017)
First-line maintenance in metastatic pancreatic adenocarcinoma with a germline BRCA mutation (POLO)
No progression after at least 16 weeks of first-line platinum chemotherapyCycle length: Continuous
No progression after at least 16 weeks of first-line platinum chemotherapy [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Olaparib | 300 mg | Oral (with or without food) | Twice daily (about every 12 hours) |
Evidence: POLO (2022), POLO (2019)
mCRPC with HRR gene mutations (PROfound)
Progression after enzalutamide or abirateroneCycle length: Continuous
Progression after enzalutamide or abiraterone [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Olaparib | 300 mg | Oral (with or without food) | Twice daily (about every 12 hours) |
| GnRH analogue | As per that drug's label | Injection | Continue concurrently (unless bilateral orchiectomy has been done) |
Evidence: PROfound (2020), PROfound (2020)
BRCA-mutated mCRPC, with abiraterone (PROpel)
With abiraterone and prednisone or prednisoloneCycle length: Continuous
With abiraterone and prednisone or prednisolone [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Olaparib | 300 mg | Oral (with or without food) | Twice daily (about every 12 hours) |
| Abiraterone | 1000 mg | Oral | Once daily |
| Prednisone or prednisolone | 5 mg | Oral | Twice daily |
| GnRH analogue | As per that drug's label | Injection | Continue concurrently (unless bilateral orchiectomy has been done) |
Evidence: PROpel (2023), PROpel (2022)
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Side effects
Common side effects
The most common side effects:
- Nausea in more than half of patients, and vomiting; if it continues, say so, so an anti-sickness medicine can be given [1].
- Tiredness and anaemia; regular blood tests are needed [1].
- Diarrhoea, poor appetite, headache, changes in taste, cough, shortness of breath, dizziness and indigestion [1].
- Low white blood cells and platelets [1].
For physicians
Among 2901 patients who received olaparib monotherapy in clinical trials, the most common adverse reactions (10% or more) were [1]:
- Nausea: 60%
- Fatigue: 55%
- Anaemia: 36%
- Vomiting: 32%
- Diarrhoea: 24%
- Decreased appetite: 22%
- Headache: 16%
- Dysgeusia: 15%
- Cough: 15%
- Neutropenia: 14%
- Dyspnoea: 14%
- Dizziness: 12%
- Dyspepsia: 12%
- Leucopenia: 11%
- Thrombocytopenia: 10%
With bevacizumab (PAOLA-1), the most common adverse reactions were nausea (53%), fatigue (53%), anaemia (41%) and lymphopenia (24%); with abiraterone (PROpel), anaemia (48%), fatigue (38%), nausea (30%) and diarrhoea (19%) [1].
Mild to moderate nausea and vomiting are very common; patients should contact the treatment team so that a suitable antiemetic can be prescribed [1].
Serious side effects
These are less common but serious; tell your team early if you notice any sign of them:
- Bone marrow diseases or leukaemia (rare, about 1 in 100 people): severe tiredness, fever or repeated infections, bruising or bleeding [1].
- Lung inflammation (rare): a new cough, shortness of breath or fever [1].
- Blood clots in the leg or lung, especially in prostate cancer: pain and swelling in one leg or sudden shortness of breath [1].
- Liver damage (yellowing), allergic reactions and harm to an unborn baby [1].
For physicians
The olaparib label has no boxed warning but includes these important warnings [1]:
- Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML): in 2219 patients the cumulative incidence was about 1.2% (26 patients), and 54% of them died; all these patients had previously received platinum-based chemotherapy and/or other DNA-damaging treatments, including radiotherapy [1]. In SOLO-2 the rate was 8% with olaparib vs 4% with placebo [1].
- Pneumonitis: 1.0% (29 of 2851 patients), including fatal cases [1].
- Venous thromboembolism: in the prostate cancer trials (PROfound and PROpel), in 8% of patients receiving olaparib (pulmonary embolism 6%) vs 2.5% in the control arms [1].
- Hepatotoxicity, including drug-induced liver injury: severe and potentially fatal cases have been reported [1].
- Embryo-fetal toxicity: based on its mechanism of action and animal findings, the drug can harm a fetus and increase the risk of miscarriage [1].
After marketing, hypersensitivity reactions (including angioedema), erythema nodosum, rash and dermatitis have also been reported [1].
When should I call my doctor?
Tell your treatment team if you have any of these symptoms [1]:
- Weakness, severe tiredness, fever, weight loss, repeated infections, bruising or bleeding easily, shortness of breath, or blood in the urine or stool (possible low blood counts or MDS/AML)
- New or worsening shortness of breath, fever, cough or wheezing
- Straight away: pain or swelling of an arm or leg, shortness of breath, chest pain, faster breathing than usual or a fast heartbeat (possible blood clot)
- Straight away: discomfort in the right side of the abdomen, dark or “tea-coloured” urine, or yellowing of the skin or whites of the eyes
- Nausea or vomiting that is not controlled by usual treatment
- Pregnancy or a possible pregnancy
In severe cases (such as sudden shortness of breath or chest pain), call your local emergency number.
Interactions, pregnancy and precautions
Other medicines: give your doctor a list of all your medicines, supplements and herbal products [1]. Some medicines change olaparib levels in the blood a lot: the antifungal itraconazole more than doubles it and the antibiotic rifampicin almost makes it ineffective [1]. So these medicines either should not be taken with it, or your doctor will change the olaparib dose [1]. Taking it with other anticancer drugs that lower blood counts makes this side effect worse and longer-lasting [1].
Food: during treatment, avoid grapefruit, grapefruit juice, Seville oranges and Seville orange juice, because they may raise the drug level in the blood [1].
Pregnancy and contraception: women who could become pregnant should use effective contraception during treatment and for 6 months after the last dose [1]. Men whose partner is pregnant or could become pregnant should use effective contraception during treatment and for 3 months after the last dose, and should not donate sperm during this time [1].
Breastfeeding: do not breastfeed during treatment and for 1 month after the last dose [1].
Missed dose: if you forget a dose, take the next dose at the usual time and do not take an extra dose to make up [1].
Vaccines: the FDA label gives no specific advice about vaccines; talk to your treatment team before any vaccination.
Storage: at 20 to 25 °C, in the original bottle to protect from moisture [1].
Frequently asked questions
Is olaparib chemotherapy?
Why is a genetic test needed before starting this drug?
Because olaparib is approved only for patients whose BRCA mutation (inherited or acquired), mutation in other HRR genes or HRD-positive status has been shown with an approved test; the type of test (blood, tumour tissue or tumour DNA in plasma) depends on the cancer [1].
How long do I need to take olaparib?
In early breast cancer 1 year, in first-line maintenance for ovarian cancer up to 2 years (with the option to continue if disease remains, at your doctor's judgement), and in other uses until the disease progresses or side effects cannot be tolerated [1].
Scientific evidence
Show detailsHide
Key studies
5 itemsOlaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer
Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer
Olaparib for Metastatic Castration-Resistant Prostate Cancer
Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer
Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer
Related cancer types
References
9 referencesShow all references, 8 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1LYNPARZA (olaparib) tablets, for oral use: Prescribing InformationSource Back to text: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101
- 2
- 3Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer
- 4Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer
- 5Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial
- 6Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation
- 7Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer
- 8Olaparib for Metastatic Castration-Resistant Prostate Cancer
- 9Abiraterone and Olaparib for Metastatic Castration-Resistant Prostate Cancer
This page is based on reputable scientific sources and was last updated on 27 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
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