Olaparib

(Lynparza)

Olaparib

Drug updated on 11/10/2023

Dosage FormTablet (oral; 100 mg, 150 mg)
Drug ClassPoly (ADP-ribose) polymerase (PARP) inhibitors
Ongoing and Completed StudiesClinicalTrials.gov

Indication

  • For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy
  • Indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability
  • For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy
  • For the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
  • For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy
  • For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
  • For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone
  • Indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

Product Monograph / Prescribing Information

Document TitleYearSource
Lynparza (olaparib) Prescribing Information.2022AstraZeneca Pharmaceuticals, Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Clinical review, pharmacoeconomic review, and stakeholder input combined report.2023CADTH
Incidence and risk of hypertension associated with PARP inhibitors in cancer patients: a systematic review and meta-analysis.2023BMC Cancer
Efficacy and safety of olaparib in advanced ovarian cancer: a meta-analysis 2023Journal of obstetrics and gynaecology
Efficacy and safety of olaparib combined with abiraterone in patients with metastatic castration-resistant prostate cancer: a systematic review and meta-analysis of randomized controlled trials2023Frontiers in oncology
Efficacy and safety of olaparib in advanced ovarian cancer: a meta-analysis.2022Journal of Obstetrics and Gynaecology
Comparative Efficacy and safety of new targeted therapies and immunotherapies for metastatic triple negative breast cancer: a network meta-analysis.2022The Breast
PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical Oncology.2022The Breast
Final clinical guidance report: olaparib (Lynparza) for metastatic castration-resistant prostate cancer (mCRPC). 2021CADTH
Consolidation or maintenance systemic therapy for newly diagnosed stage II, III, or IV epithelial ovary, fallopian tube, or primary peritoneal carcinoma: a systematic review.2021Critical Reviews in Oncology/Hematology
PARP (Poly ADP-Ribose Polymerase) inhibitors for locally advanced or metastatic breast cancer.2021Cochrane Database of Systematic Reviews
Comparative safety and tolerability of approved PARP inhibitors in cancer: a systematic review and network meta-analysis.2021Pharmacological Research
Specific toxicity of maintenance olaparib versus placebo in advanced malignancies: a systematic review and meta-analysis.2020Anticancer Research
Evaluation of the efficacy and safety of PARP inhibitors in advanced-stage epithelial ovarian cancer.2020Frontiers in Oncology
A Bayesian network meta-analysis of the efficacy of targeted therapies and chemotherapy for treatment of triple-negative breast cancer.2020Cancer Medicine
Clinical guidance report: olaparib (Lynparza) for newly diagnosed ovarian cancer.2019CADTH
Australian public assessment report for olaparib.2019Government of Australia: Department of Health

Clinical Practice Guidelines