Lynparza (Olaparib): gBRCAm, HER2-negative breast cancer

Prescribing Information LYNPARZA (olaparib) United Kingdom

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With over a decade of real-world use, LYNPARZA has been prescribed to more than 140,000 eligible patients worldwide across five tumour types^1,6

Consider LYNPARZA for your eligible patients with gBRCAm, HER2-negative breast cancer.

LYNPARZA is a guideline-recommended, targeted treatment option for eligible patients with gBRCAm, HER2-negative breast cancer¹

High-risk eBC

Licensed indication:
As monotherapy or in combination with ET for the adjuvant treatment of adult patients with gBRCA1/2-mutations who have HER2-negative, high-risk eBC who have previously been treated with neoadjuvant or adjuvant chemotherapy.¹

NHS funding:
LYNPARZA is NICE-recommended and SMC-accepted for the adjuvant treatment of patients with gBRCAm, HER2-negative, high-risk eBC after chemotherapy.^2,3

aBC

Licensed indication:
As monotherapy for the treatment of adult patients with gBRCA1/2-mutations, who have HER2-negative locally advanced or mBC. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with HR+ breast cancer should also have progressed on or after prior ET or be considered unsuitable for ET.¹

NHS funding:
LYNPARZA is NICE-recommended and SMC-accepted for the treatment of patients with gBRCAm, HER2-negative aBC after chemotherapy.^4,5

ESMO guidelines recommend the use of adjuvant LYNPARZA in eligible patients with gBRCAm, HER2-negative, high-risk eBC previously treated with neoadjuvant or adjuvant chemotherapy – including both TNBC and HR+ subtypes⁹

LYNPARZA has been scored a Grade A ESMO Magnitude of Clinical Benefit Scale score based on data from the OlympiA trial¹⁰

ESMO guidelines recommend LYNPARZA as a treatment option for eligible patients with gBRCAm, HER2-negative aBC – including in both TNBC and HR+ subtypes⁹

LYNPARZA has been awarded a Grade 4 ESMO Magnitude of Clinical Benefit Scale score based on data from the OlympiAD trial¹¹

LYNPARZA is supported by efficacy and safety data in patients with HER2-negative, gBRCAm breast cancer – both in high-risk eBC in the OlympiA trial and in mBC in the OlympiAD trial.^7,8

Review the data from the pivotal Phase III trials:

Visit OlympiA

Visit OlympiAD

Patients with BRCA mutations are a distinct population who often present with aggressive disease and may have poor survival outcomes^12–14

*In BRCA1/2-mutated women vs. general population.¹⁶

BRCA testing at diagnosis is critical to inform a targeted treatment and surgical approach. Germline testing for BRCAm should be offered to patients who meet eligibility criteria.⁹

Learn more

A real-world US database study analysed 2,968 patients with HR+/HER2-negative aBC, of which 859 (28.9%) had a known germline BRCA status and 85 (9.9%) were gBRCAm.²¹

When a CDK4/6i was initiated 1L, median OS was:²¹

LYNPARZA is a PARP inhibitor that selectively kills tumour cells that have a deficiency in homologous recombination repair^22†

gBRCAm have a unique molecular biology that makes them susceptible to PARP inhibition:^22–24

^†In vitro activity does not always correlate with clinical efficacy.

LYNPARZA is an oral therapy taken twice daily at home¹

The recommended daily dose of LYNPARZA is 300 mg (two x 150 mg tablets) taken orally twice daily with or without food (total 600 mg daily).

Please refer to the SmPC for further guidance on dose interruption and reductions.¹

The importance of

BRCA testing

Find out more

OlympiA: clinical

trial in eBC

Find out more

OlympiAD: clinical

trial in mBC

Find out more

Educational and

patient resources

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1L, first-line; aBC, advanced breast cancer; AE, adverse event; BRCA, breast cancer gene; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CNS, central nervous system; DNA, deoxyribonucleic acid; eBC, early breast cancer; ESMO, European Society for Medical Oncology; ET, endocrine therapy; gBRCAm, germline breast cancer gene mutation; gBRCAwt, germline breast cancer gene wild-type; HER2, human epidermal growth factor 2; HR+, hormone receptor positive; mBC, metastatic breast cancer; NICE, National Institute for Health and Care Excellence; OS, overall survival; PARP, poly (ADP-ribose) polymerase; RWE, real-world evidence; SMC, Scottish Medicines Consortium; SmPC, Summary of Product Characteristics; TNBC, triple-negative breast cancer.

LYNPARZA (olaparib). Summary of Product Characteristics.
NICE TA886. Available at: https://www.nice.org.uk/guidance/ta886. Accessed March 2026.
SMC 2581. Available at: https://scottishmedicines.org.uk/media/7876/olaparib-lynparza-final-sept-2023-amended-210923-for-website.pdf. Accessed March 2026.
NICE TA1040. Available at: https://www.nice.org.uk/guidance/ta1040. Accessed March 2026.
SMC 2737. Available at: https://scottishmedicines.org.uk/medicines-advice/olaparib-lynparza-abb-smc2737/. Accessed March 2026.
Rose M, et al. Front Cell Dev Biol. 2020;8:564601.
Robson M, et al. N Engl J Med. 2017;377(6):523–533
Tutt ANJ, et al. N Engl J Med. 2021;384(25):2394–2405.
ESMO Breast Cancer Pocket Guideline 2024. Available at: https://interactiveguidelines.esmo.org/esmo-web-app/toc/index.php?subjectAreaID=8&loadPdf=1. Accessed March 2026.
European Society for Medical Oncology (ESMO). ESMO-MCBS Scorecard for olaparib. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-331-1. Accessed March 2026.
European Society for Medical Oncology (ESMO). ESMO-MCBS Scorecard for olaparib. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards?scorecard=166. Accessed March 2026.
Baretta Z, et al. Medicine. 2016;95(40):e4975.
Becourt S, et al. J Clin Oncol. 2018;36(15_suppl): Abstract e13522.
Liu M, et al. Breast Cancer Res Treat. 2021;186(3):591–605.
Song Y, et al. Cancer. 2020;126(2):271–280.
BRCA gene mutations: Cancer risk and genetic testing. National Cancer Institute. Available at: https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet. Accessed March 2026.
Green L and Meric-Bernstam F. Curr Breast Cancer Rep. 2011;3(3):151–155.
Valachis A, et al. Breast Cancer Res Treat. 2014;144(3):443–455.
Cancer stat facts: Female breast cancer. National Cancer Institute. Available at: https://seer.cancer.gov/statfacts/html/breast.html. Accessed March 2026.
Krammer J, et al. Breast Cancer Res Treat. 2017;163(3):565–571.
Collins JM, et al. Status Oncol Ther. 2021;9(2):575–589.
Tutt ANJ, et al. Lancet 2010;376:235–44.
Nijman SMB. FEBS Lett. 2011;585(1):1–6.
O'Connor MJ. Mol Cell. 2015 Nov;60(4):547–60.

GB-71734 | March 2026

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This website was created for UK HCPs and has been designed to provide information to educate, empower and enable them in the great work they are doing for patients across a range of therapy areas. This website is intended for doctors, nurses, and pharmacists in the UK. Other UK residents please visit astrazeneca.co.uk.

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With over a decade of real-world use, LYNPARZA has been prescribed to more than 140,000 eligible patients worldwide across five tumour types1,6

LYNPARZA is a guideline-recommended, targeted treatment option for eligible patients with gBRCAm, HER2-negative breast cancer1

High-risk eBC

aBC

High-risk eBC: ESMO recommendations

aBC: ESMO recommendations

LYNPARZA is supported by efficacy and safety data in patients with HER2-negative, gBRCAm breast cancer – both in high-risk eBC in the OlympiA trial and in mBC in the OlympiAD trial.7,8

Patients with BRCA mutations are a distinct population who often present with aggressive disease and may have poor survival outcomes12–14

BRCA testing at diagnosis is critical to inform a targeted treatment and surgical approach. Germline testing for BRCAm should be offered to patients who meet eligibility criteria.9

RWE suggests that patients with gBRCAm in HR+/HER2-negative aBC may have shorter survival on 1L CDK4/6i + ET compared to those without these mutations21

LYNPARZA is a PARP inhibitor that selectively kills tumour cells that have a deficiency in homologous recombination repair22†

LYNPARZA is an oral therapy taken twice daily at home1

Treatment interruption and dose reductions can be considered to manage adverse reactions1

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Abbreviations and References

With over a decade of real-world use, LYNPARZA has been prescribed to more than 140,000 eligible patients worldwide across five tumour types^1,6

LYNPARZA is a guideline-recommended, targeted treatment option for eligible patients with gBRCAm, HER2-negative breast cancer¹

LYNPARZA is supported by efficacy and safety data in patients with HER2-negative, gBRCAm breast cancer – both in high-risk eBC in the OlympiA trial and in mBC in the OlympiAD trial.^7,8

Patients with BRCA mutations are a distinct population who often present with aggressive disease and may have poor survival outcomes^12–14

BRCA testing at diagnosis is critical to inform a targeted treatment and surgical approach. Germline testing for BRCAm should be offered to patients who meet eligibility criteria.⁹

LYNPARZA is a PARP inhibitor that selectively kills tumour cells that have a deficiency in homologous recombination repair^22†

LYNPARZA is an oral therapy taken twice daily at home¹