Prescribing Information LYNPARZA (olaparib) United Kingdom

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LYNPARZA in monotherapy

PROfound study design
Efficacy
Safety
Molecular testing

Time to challenge expectations in mCRPC treatment for patients with BRCA1/2 mutations

LYNPARZA monotherapy is recommended by NICE and accepted by SMC for treating hormone-relapsed mCRPC with BRCA1/2-mutations that has progressed after NHA (such as abiraterone or enzalutamide) in adults.^1,2

LYNPARZA tablets are indicated as monotherapy for the treatment of adult patients with mCRPC and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included an NHA.³

PROfound was the first study evaluating the efficacy and safety of LYNPARZA monotherapy vs NHAs in patients with HRRm mCRPC^3–6

Basic outline of the PROfound study design

LYNPARZA (tablets) is indicated as monotherapy for the treatment of adult patients with mCRPC and BRCA1/2 gene mutations (germline and/or somatic) who have progressed following a prior NHA.³

*Cohort A included patients with BRCA1, BRCA2 or ATM mutations, Cohort B included patients with BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D or RAD54L mutations.

^†Physician’s choice of either enzalutamide or abiraterone.

Table containing PROfound baseline characteristics

Adapted from LYNPARZA SmPC and de Bono et al. 2020^3,4

LYNPARZA (tablets) is indicated as monotherapy for the treatment of adult patients with mCRPC and BRCA1/2 gene mutations (germline and/or somatic) who have progressed following a prior NHA³

*Cohort A included patients with BRCA1, BRCA2 or ATM mutations, Cohort B included patients with BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D or RAD54L mutations.

^†The study was not powered for gene-by-gene analysis. ‡Physician’s choice of either enzalutamide or abiraterone.

Discover the efficacy outcomes for LYNPARZA monotherapy

LYNPARZA monotherapy is indicated for mCRPC in patients with BRCA1/2 mutations who have progressed following prior therapy with a NHA^3,4

An exploratory analysis of the PROfound trial assessed the efficacy of LYNPARZA monotherapy in mCRPC patients with BRCA1/2 mutations.^3,4

In patients with BRCA mutations, median imaging-based PFS was 9.8 months in the experimental arm vs 3.0 months in the control arm.*⁴

P not tested

rPFS by BICR in patients with alterations in BRCA1/2 (as licensed)

Kaplan-Meier graph with descending purple and yellow lines with a purple call-out box reading "9.8 months median rPFS" and a yellow call-out box reading "3.0 months median rPFS"

Adapted from de Bono J et al. 2020.⁴

*A small number of patients were censored in the rPFS analysis because they were lost to follow-up/withdrew consent. This included patients that missed two consecutive soft tissue or bone assessment appointments and experienced disease progression or death. As the numbers of patients who were lost to follow-up were small, comparisons are challenging to make, and there are no clear differences between these sub-populations. An exploratory sensitivity analysis was conducted to consider the impact of censoring these patients on rPFS.

^†Physician’s choice of either enzalutamide or abiraterone.

The most common AEs (≥15% of patients) in PROfound were consistent with prior studies of other tumour types*⁷

Bar graph with purple, green and blue bars to represent LYNPARZA, NHA alone, and crossover, respectively. Graph shows LYNPARZA generally had a higher proportion of AEs when compared with NHA alone and crossover

Adapted from Hussain et al. 2020.⁷

Data cut-off: 20 March 2020.

*Patients had alterations in BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D and/ or RAD54L.

^†Physician’s choice of either abiraterone or enzalutamide.

^‡Patients in the physician’s choice group were allowed to cross over to receive LYNPARZA after disease progression in accordance with the protocol.

^§Grouped term includes anaemia, decreased haemoglobin level, decreased red-cell count, decreased haematocrit level, erythropenia, macrocytic anaemia, normochromic anaemia, normochromic normocytic anaemia, and normocytic anaemia.

^‖MDS/AML and VTE are listed as special warnings in the SmPC. Please refer to the SmPC for further details on these and other listed special warnings.

^¶The safety analyses conducted at the time of the primary analysis revealed an imbalance between the two treatment arms in the incidence of pulmonary embolism (4% with LYNPARZA vs. 1% with control therapy). There has since been one additional case of pulmonary embolism in the LYNPARZA treatment arm; the rate of pulmonary embolism with LYNPARZA after this longer follow-up was thus similar to that reported in the primary analysis (5% vs. 1%). Patients receiving LYNPARZA should be monitored for clinical signs and symptoms of VTE and PE and treated as medically appropriate. Patients with a prior history of VTE may be more at risk of a further occurrence and should be monitored appropriately.

The majority of patients remained on the full dose of LYNPARZA without a dose reduction due to AEs^3,7

Table containing PROfound adverse events in LYNPARZA treatment group, placebo group and crossover

Two pie charts - left: No dose reduction pie chart with 77% in the middle right: No discontinuations pie chart with 80% in the middle

Data cut-off: 20 March 2020.

4 out of 5 patients remain on LYNPARZA monotherapy without discontinuation due to AEs, however 46% of patients did require a dose interruption.⁷

For full details on the LYNPARZA special warnings and precautions, and drug interactions please refer to the Summary of Product Characteristics.³

Molecular testing

Germline and somatic BRCA mutations have been found in prostate cancer tumour cells⁸ with approximately 10% of patients with mCRPC screened for inclusion in the PROfound trial having a BRCA mutation.⁹ Approximately half of those with a germline mutation were identified as having a BRCA mutation.⁸

Pathway chart of the different options available when referring patients with prostate cancer for BRCA testing

A failed BRCA tumour test is not the same as a negative test result.⁹

Discover the dosing regimen for LYNPARZA monotherapy

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Learn how to manage possible adverse events in patients receiving LYNPARZA

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You can challenge NHA-naive mCRPC with LYNPARZA combination therapy

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Want to learn more about LYNPARZA?

ADT=androgen deprivation therapy; AE=adverse event; AML=acute myeloid leukaemia; BICR=blinded independent central review; BID=twice a day; BRCA1/2m=BRCA1/2 mutation; CBC=complete blood count; CTCAE=Common Terminology Criteria for Adverse Events; ctDNA=circulating tumour DNA; ECOG PS=Eastern Cooperative Oncology Group Performance Status; FACT-G TS=Functional Assessment of Cancer Therapy–General total score; FACT-P TS=Functional Assessment of Cancer Therapy–Prostate total score; FAPSI-6=Functional Assessment of Cancer Therapy Advanced Prostate Symptom Index 6; FWB=functional wellbeing; HR=hazard ratio; HRQoL=health-related quality of life; HRR=homologous recombination repair; HRRm=homologous recombination repair mutation; LFT=liver function test; mCRPC=metastatic castration-resistant prostate cancer; MDS=myelodysplastic syndrome; mOS=median overall survival; mPC=metastatic prostate cancer; NHA=new hormonal agent; NICE=National Institute for Health and Care Excellence; OS=overall survival; PCS=prostate cancer subscale; PCWG3=Prostate Cancer Working Group 3; PE=pulmonary embolism; PO=orally; PWB=physical wellbeing; RECIST=Response Evaluation Criteria in Solid Tumors; rPFS=radiographic progression‑free survival; SMC=Scottish Medicines Consortium; TOI=Trial Outcome Index; VTE=venous thromboembolism.

Olaparib for previously treated BRCA mutation-positive hormone-relapsed metastatic prostate cancer. May 2023. https://www.nice.org.uk/guidance/ta887/resources/olaparib-for-previously-treated-brca-mutationpositive-hormonerelapsed-metastatic-prostate-cancer-pdf-82613738657221. Accessed January 2026.
Scottish Medicines Consortium. Olaparib (Lynparza). October 2021. Available at: https://www.scottishmedicines.org.uk/medicines-advice/olaparib-lynparza-full-smc2366/ Accessed January 2026.
LYNPARZA (olaparib). Summary of Product Characteristics. https://www.medicines.org.uk/emc/product/9488. Accessed January 2026.
de Bono J, et al. N Engl J Med. 2020;382:2091–2102; Supplemental data.
Clinicaltrials.gov. Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study). Available at: https://www.clinicaltrials.gov/study/NCT02987543 Accessed January 2026.
Thiery-Vuillemin A, et al. Lancet Oncol. 2022;23:393–405; Supplemental data.
Hussain M, et al. N Engl J Med. 2020;383:2345–2357; Supplemental data.
Abida W, et al. JCO Precis Oncol. 2017;2017:PO.17.00029.
de Bono J, et al. Poster presented at ESMO Annual Congress 2019. 27 September–1 October. Barcelona, Spain. Poster 847PD
Boerrigter E, et al. Exp Rev Mol Diagn. 2020;20:219–230.
Gillessen S, et al. Eur Urol. 2020;77:508–547.
Parker C, et al. Ann Oncol. 2020;31:1119–1134.
Yadav S, et al. Fam Cancer. 2017;16:319–328.
NHS Wales. Cancer Network. Clinical Guidance for BRCA Gene Testing for Hormone-Relapsed Metastatic Prostate Cancer. performanceandimprovement.nhs.wales/functions/networks-and-planning/cancer/wcn-documents/genomics/brca-testing-for-olaparib-use-in-prostate-cancer-clinical-guidance-document/. Accessed January 2026.
Gonzalez D, et al. J Pathol Clin Res. 2021; 7:311–325.

GB-73795 | DOP: February 2026

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LYNPARZA in monotherapy

Time to challenge expectations in mCRPC treatment for patients with BRCA1/2 mutations

PROfound was the first study evaluating the efficacy and safety of LYNPARZA monotherapy vs NHAs in patients with HRRm mCRPC^3–6