In this installment of our Guidelines+ Monographs Series, we will delve into the medication olaparib, marketed under the brand name Lynparza by AstraZeneca. Lynparza, is a poly ADP ribose polymerase (PARP) inhibitor for the treatment of ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer. It was initially approved in 2014.

In the following sections, we will provide a comprehensive overview of olaparib and analyze its positioning across various guidelines for its approved indications.

Note* – This Guidelines+ Monographs for olaparib (Lynparza) is current as of September 2024. Consult our clinical guidelines library and/or medication information lookup tool to ensure you are always accessing the most current information.

Medication Overview: 

  • Generic Name: olaparib
  • Brand Name: Lynparza
  • Pharmaceutical Manufacturer: AstraZeneca
  • Initial approval in the U.S.: December 2014

Indications and FDA Approval Details

Indicated ConditionIndicated ForAge Range
Ovarian Cancer• 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. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. 

• 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. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. 

• 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. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.		Adults
Breast Cancer• 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. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. 

• 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. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.		Adults
Pancreatic Cancer• 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. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.Adults
Prostate Cancer• 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. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

• 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). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. 		Adults

Dosage Forms and Strengths

Dosage FormStrength
Lynparza (olaparib) oral tablets150 mg
Lynparza (olaparib) oral tablets100 mg

Dosage and Administration

Recommended dosage is 300 mg taken orally twice daily with or without food. See Full Prescribing Information for the recommended duration. 

  •  Patients receiving Lynparza for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. 
  •  For moderate renal impairment (CLcr 31-50 mL/min), reduce Lynparza dosage to 200 mg orally twice daily. 

Key Warnings and Precautions

  • Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.2% of patients with various BRCAm, gBRCAm, HRR gene-mutated or HRD-positive cancers exposed to Lynparza and the majority of events had a fatal outcome. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed. 
  • Pneumonitis: Occurred in 0.8% of patients exposed to Lynparza, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed. 
  • Venous thromboembolism (VTE), including severe or fatal pulmonary embolism (PE), occurred in patients treated with Lynparza. VTE occurred in 8% of patients with mCRPC. Monitor patients for signs and symptoms of VTE and PE and treat as medically appropriate. 
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception.

Adverse Reactions

Some of the side effects patients could experience are:

  • Nausea
  • Fatigue (including asthenia)
  • Anemia
  • Vomiting
  • Diarrhea
  • Decreased appetite
  • Headache
  • Dysgeusia
  • Cough
  • Neutropenia
  • Dyspnea
  • Dizziness
  • Dyspepsia
  • Leukopenia
  • Thrombocytopenia 

In combination with bevacizumab:

  • Nausea
  • Fatigue (including asthenia)
  • Anemia
  • Lymphopenia
  • Vomiting
  • Diarrhea
  • Neutropenia
  • Leukopenia
  • Urinary tract infection
  • Headache

In combination with abiraterone and prednisone or prednisolone:

  • Anemia
  • Fatigue
  • Nausea
  • Diarrhea 
  • Decreased appetite 
  • Lymphopenia 
  • Dizziness 
  • Abdominal pain

*This is only some of the possible adverse reactions someone may have after administering Lynparza.

Specific Inclusions of Lynparza in Clinical Guidelines:
  • Biomarkers for Systemic Therapy in Metastatic Breast Cancer
    • Authoring Society: American Society of Clinical Oncology (ASCO)
    • Publication Date: March 13, 2024
    • Recommendation(s):
      • Patients with metastatic HER2-negative breast cancer who are candidates for treatment with poly [ADP-ribose] polymerase (PARP) inhibitor should undergo testing for germline BRCA1 and BRCA2 pathogenic or likely pathogenic mutations o determine their eligibility for treatment with the PARP inhibitors olaparib or talazoparib. 
  • Metastatic HER2-Negative Breast Cancer – Chemo- and Targeted Therapy
    • Authoring Society: American Society of Clinical Oncology (ASCO)
    • Publication Date: January 9, 2023
    • Recommendation(s):
      • Patients with metastatic triple negative breast cancer with germline BRCA 1 or 2 mutations who have previously been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic disease setting may be offered an oral PARP inhibitor (olaparib or talazoparib) rather than chemotherapy.
  • PARP Inhibitors in the Management of Ovarian Cancer
    • Authoring Society: American Society of Clinical Oncology (ASCO)
    • Publication Date: September 23, 2022
    • Recommendation(s):
      • Recommendation 2.1. Patients with newly diagnosed stage III-IV EOC who are in complete or partial response to first-line platinum-based chemotherapy should be offered PARPi maintenance therapy in high-grade serous or endometrioid ovarian cancer. For those with germline or somatic pathogenic or likely pathogenic variants in BRCA1 or BRCA2 genes, options should include olaparib (300 mg orally every 12 hours for 2 years), niraparib (200-300 mg orally daily for 3 years) or rucaparib (600 mg twice a day for 2 years). Longer duration could be considered in selected individuals after discussion of risks. For those who are HRD positive, determined using FDA-approved companion diagnostic tests, rucaparib and niraparib are options. Niraparib or rucaparib may be offered for non-BRCAmut/HRDneg patients.
      • Recommendation 3.0. PARPi monotherapy maintenance (second-line or more) may be offered to patients with EOC who have not already received a PARPi and who have responded to platinum-based therapy regardless of BRCA mutation status; treatment is continued until progression of disease or toxicity despite dose reductions and best supportive care. Options include olaparib 300 mg every 12 hours, rucaparib 600 mg every 12 hours or niraparib 200-300 mg once daily. (Type: Evidence-based, benefits outweigh harms; Evidence quality: High; Strength of recommendation: Strong.) Maintenance treatment with niraparib for patients without germline or somatic BRCA mutation should weigh potential PFS benefit against possible OS decrement. 
  • Management of Hereditary Breast Cancer
    • Authoring Society: American Society of Clinical Oncology (ASCO), American Society for Radiation Oncology (ASTRO), and Society of Surgical Oncology (SSO)
    • Publication Date: August 3, 2021
    • Recommendation(s):
      • For BRCA 1/2 mutation carriers with metastatic HER2-negative breast cancer, olaparib or talazoparib should be offered as an alternative to chemotherapy in the 1st-3rd line setting. For BRCA 1/2 mutation carriers with metastatic HER2-negative breast cancer, there are no data directly comparing efficacy of PARP inhibitor to platinum chemotherapy. 
      • For patients with early-stage, HER2-negative breast cancer with high risk of recurrence and germline BRCA 1 or BRCA 2 pathogenic or likely pathogenic variants, one year of one year of adjuvant olaparib should be offered after completion of (neo)adjuvant chemotherapy and local treatment, including radiation.
        • For those who had surgery first, 1 year of adjuvant olaparib should be offered for patients with triple-negative breast cancer and tumor size > 2 cm or any involved axillary nodes. 
        • For those with hormone receptor–positive disease, 1 year of adjuvant olaparib should be offered to those with at least four involved axillary lymph nodes. 
        • For patients who had neoadjuvant chemotherapy, 1 year of adjuvant olaparib should be offered to patients with triple-negative breast cancer and any residual cancer; for patients with hormone receptor–positive disease, 1 year of adjuvant olaparib should be offered to patients with residual disease and a clinical stage, pathologic stage, estrogen receptor, and tumor grade score ≥ 3.
  • Metastatic Pancreatic Cancer
    • Authoring Society: American Society of Clinical Oncology (ASCO)
    • Publication Date: August 5, 2020
    • Recommendation(s):
      • In patients who have a germline BRCA1 or BRCA2 mutation and who have received first-line platinumbased chemotherapy without disease progression for at least 16 weeks, options for continued treatment include chemotherapy or PARP inhibitor olaparib.
      • PARP inhibitor olaparib is a recommended treatment option as maintenance therapy, based on a statistically significant benefit in PFS compared with placebo. Olaparib was approved by the FDA on December 27, 2019, for the maintenance treatment of adult patients with germline BRCA mutations and metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of first-line platinum-based chemotherapy.

The information provided here on Lynparza (olaparib) highlights its role in the ongoing management of ovarian, breast, pancreatic and prostate cancers. As with any medication, it’s crucial to be aware of its indications, dosing, potential side effects, and contraindications to ensure safe and effective use.

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