Drug updated on 4/16/2024
| Dosage Form | Tablet (oral; 100 mg, 150 mg) |
| Drug Class | Poly (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
- 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 Title | Year | Source |
|---|---|---|
| Lynparza (olaparib) prescribing information. | 2023 | AstraZeneca Pharmaceuticals, Wilmington, DE |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| An Ontario Health (Cancer Care Ontario) clinical practice guideline: consolidation or maintenance systemic therapy for newly diagnosed stage II, III, or IV epithelial ovary, fallopian tube, or primary peritoneal carcinoma. | 2021 | Current Oncology |
| Advanced/metastatic prostate cancer. | 2021 | Alberta Health Services |
| Endocrine treatment and targeted therapy for hormone receptor–positive, human epidermal growth factor receptor 2 - negative metastatic breast cancer: ASCO guideline update. | 2021 | Journal of Clinical Oncology |
| eUpdate - newly diagnosed epithelial ovarian carcinoma treatment recommendations, clinical practice guideline | 2021 | European Society for medical Oncology |
| PARP inhibitors in the management of ovarian cancer: ASCO guideline. | 2020 | Journal of Clinical Oncology |