Olaparib

(Lynparza®)

Lynparza®

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Drug updated on 4/16/2024

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

Indication

  • Indicated 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.
  • Indicated 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.
  • Indicated 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.
  • Indicated 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.
  • Indicated 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.
  • Indicated 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).

Summary
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  • Olaparib (Lynparza) is indicated for the maintenance treatment of adult patients with various types of cancer, including ovarian, fallopian tube, or primary peritoneal cancer; breast cancer; pancreatic adenocarcinoma, and prostate cancer. These cancers may harbor BRCA mutations or exhibit homologous recombination deficiency (HRD).
  • A comprehensive review was conducted on 21 systematic reviews/meta-analyses related to Olaparib.
  • In terms of safety and effectiveness, Olaparib significantly improves progression-free survival in patients with advanced ovarian cancer, especially those with BRCA mutations. It has a superior benefit compared to placebo and chemotherapy in both newly-diagnosed and recurrent settings.
  • For metastatic castration-resistant prostate cancer (mCRPC), combinations involving Olaparib have demonstrated significant improvements without markedly worsening the overall safety profile despite an increased incidence of high-grade anemia.
  • In HER2-negative and BRCA-mutated advanced breast cancers, Olaparib enhances not only progression-free survival but also likely overall survival rates over chemotherapy, indicating its therapeutic advantage within this population group.
  • The drug's indication for use in treating BRCA-mutated metastatic pancreatic adenocarcinoma following platinum-based chemotherapy showcases its applicability beyond just ovarian and breast cancers.
  • Population considerations reveal that Olaparib's efficacy is most pronounced among genetically defined subgroups across different disease sites, which supports genetic testing as necessary for optimal treatment stratification.
  • Regardless of prior treatments such as chemotherapy or antiandrogen therapy, particularly in cases like ovarian and prostate cancers, benefits from using Olaparib appear consistent, making it a robust option for maintenance therapy.

Product Monograph / Prescribing Information

Document TitleYearSource
Lynparza (olaparib) prescribing information.2023AstraZeneca Pharmaceuticals, Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
PARP inhibitor era in ovarian cancer treatment: a systematic review and meta-analysis of randomized controlled trials.2024Journal of Ovarian Research
Combining PARP inhibitors and androgen receptor signalling inhibitors in metastatic prostate cancer: a quantitative synthesis and meta-analysis.2024European Urology Oncology
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
Combining novel hormonal therapies with a poly (ADP-Ribose) polymerase inhibitor for metastatic castration-resistant prostate cancer: emerging evidence. 2023Current Oncology
Hematological toxicity of PARP inhibitors in metastatic prostate cancer patients with mutations of BRCA or HRR genes: a systematic review and safety meta-analysis. 2023Targeted Oncology
Addition of olaparib to the new hormonal agent regimen for metastatic castration-resistant prostate cancer: a systematic review and meta-analysis.2023World Journal of Oncology
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 trials.2023Frontiers in Oncology
Poly (ADP-ribose) polymerase inhibitors have comparable efficacy with platinum chemotherapy in patients with BRCA-positive metastatic castration-resistant prostate cancer: a systematic review and meta-analysis. 2023European Urology Oncology
Comparative Efficacy and safety of new targeted therapies and immunotherapies for metastatic triple negative breast cancer: a network meta-analysis.2022Expert Opinion on Drug Safety
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
The molecular mechanisms of actions, effects, and clinical implications of PARP inhibitors in epithelial ovarian cancers: a systematic review. 2022International Journal of Molecular Sciences
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
Efficacy and safety exposure-response analyses of olaparib capsule and tablet formulations in oncology patients.2019Clinical Pharmacology and Therapeutics
Bridging olaparib capsule and tablet formulations using population pharmacokinetic meta-analysis in oncology patients.2019Clinical Pharmacokinetics

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