ICYMI: What a gBRCA mutation could mean for certain patients with HER2-negative early breast cancer.
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SELECT SAFETY INFORMATION: LYNPARZA is associated with serious and potentially fatal adverse events including myelodysplastic syndrome/acute myeloid leukemia (MDS/ AML), pneumonitis, venous thromboembolism (VTE) and drug-induced liver injury (DILI). Monitor patients for signs and symptoms and discontinue LYNPARZA if MDS/AML or pneumonitis is confirmed. Monitor patients for signs and symptoms of VTE and treat as medically appropriate. Evaluate bilirubin and transaminases at baseline and throughout treatment with LYNPARZA. If DILI is suspected, interrupt LYNPARZA. If DILI is confirmed, discontinue LYNPARZA. LYNPARZA can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception.
*Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.¹
^(†)For patients who received prior neoadjuvant chemotherapy, high risk was defined as non-pCR in TNBC and as non-pCR with CPS&EG score ≥3 in HR-positive, HER2-negative disease. For patients who received prior adjuvant chemotherapy, high risk was defined as ≥pN1 or with ≥pT2 in TNBC and as ≥4 positive lymph nodes in HR-positive, HER2-negative disease.¹
^(‡)Treatment was continued for up to 1 year, or until disease recurrence, or unacceptable toxicity.¹
^(§)IDFS was defined as time to first invasive breast cancer recurrence (loco-regional or distant), secondary primary cancer, or death from any cause.¹
^(‖)OS is a key secondary endpoint in the OlympiA trial.^(1,2)
OlympiA
Primary endpoint: IDFS**^(2)**
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The number of IDFS events observed was 106 with LYNPARZA (n=921) 178 with placebo (n=915) at a median follow-up of 2.5 years.¹
Key secondary endpoint: OS**^(1)**
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The number of deaths was 75 with LYNPARZA (n=921) vs 109 with placebo (n=915) at a median follow-up of 3.5 years.¹
INDICATION
LYNPARZA is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm,* 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.
SELECT SAFETY INFORMATION
LYNPARZA is associated with serious and potentially fatal adverse events including myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), pneumonitis, venous thromboembolism (VTE) and drug-induced liver injury (DILI). Monitor patients for signs and symptoms and discontinue LYNPARZA if MDS/AML or pneumonitis is confirmed. Monitor patients for signs and symptoms of VTE and treat as medically appropriate. Evaluate bilirubin and transaminases at baseline and throughout treatment with LYNPARZA. If DILI is suspected, interrupt LYNPARZA. If DILI is confirmed, discontinue LYNPARZA. LYNPARZA can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception.
Please see complete Important Safety Information below.
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SEE WHAT’S POSSIBLE WITH LYNPARZA
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
There are no contraindications for LYNPARZA.
WARNINGS AND PRECAUTIONS
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.2% of patients (26/2219) with various BRCAm, gBRCAm, HRR gene-mutated or HRD-positive cancers who received LYNPARZA in clinical studies as a single agent or as part of a combination regimen, consistent with the approved indications, and the majority of events had a fatal outcome. The median duration of therapy in patients who developed MDS/AML was approximately 2 years (range: <6
months to >4 years). All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.
Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.
Pneumonitis: Including severe and fatal cases, has occurred in patients treated with LYNPARZA. In clinical studies, among patients who received LYNPARZA as a single agent or as part of a combination regimen, the incidence of pneumonitis, including fatal cases, was 1.0% (29/2851). If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and promptly assess the source of the symptoms. If pneumonitis is confirmed, discontinue LYNPARZA treatment and treat the patient appropriately.
Venous Thromboembolism (VTE): Including severe or fatal pulmonary embolism (PE), occurred in patients treated with LYNPARZA. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated.
Hepatotoxicity, including Drug-Induced Liver Injury (DILI): Hepatotoxicity, including severe and potentially fatal cases of DILI has occurred in patients treated with LYNPARZA. Evaluate bilirubin and transaminases at baseline and throughout treatment with LYNPARZA. For patients who develop abnormal liver tests after LYNPARZA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold LYNPARZA. Upon confirmation of DILI, discontinue LYNPARZA.
Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. Verify pregnancy status in females of reproductive potential prior to initiating treatment.
Females
Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.
Males
Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.
ADVERSE REACTIONS—Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer
Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: nausea (57%), fatigue (including asthenia) (42%), anemia (24%), vomiting (23%), headache (20%), diarrhea (18%), leukopenia (17%), neutropenia (16%), decreased appetite (13%), dysgeusia (12%), dizziness (11%), and stomatitis (10%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: decrease in lymphocytes (77%), increase in mean corpuscular volume (67%), decrease in hemoglobin (65%), decrease in leukocytes (64%), and decrease in absolute neutrophil count (39%).
DRUG INTERACTIONS
Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.
CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.
CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.
USE IN SPECIFIC POPULATIONS
Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.
Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.
Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).
Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min).
Please see complete Prescribing Information, including Medication Guide.
You may report side effects related to AstraZeneca products.
Cl=confidence interval; CPS&EG=pre-treatment clinical and post-treatment pathologic stage (CPS), estrogen receptor (ER) status, and histologic grade; eBC=early breast cancer; gBRCA=germline BRCA; gBRCAm=germline BRCA-mutated; HER2=human epidermal growth factor receptor 2; HR=hormone receptor and hazard ratio; HRD=homologous recombination deficiency; HRR=homologous recombination repair; IDFS=invasive disease-free survival; OS=overall survival; pCR=pathologic complete response; pN0=no cancer cells found in regional lymph nodes during pathologic examination after surgery; pN1=pathologically confirmed regional lymph node metastasis; pT2=tumor size >2 cm to ≤5 cm; TNBC=triple-negative breast cancer.
References: 1. LYNPARZA® (olaparib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 2. Tutt ANJ, Garber JE, Kaufman B, et al; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer. N Engl J Med. 2021;384(25):2394-2405. 3. Geyer CE Jr, Garber JE, Gelber RD, et al; OlympiA Clinical Trial Steering Committee and Investigators. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022;33(12):1250-1268. 4. Rubraca®
(rucaparib) [prescribing information]. Vienna, Austria: zr pharma& GmbH; 2025. 5. Talzenna® (talazoparib) [prescribing information]. New York, NY: Pfizer Inc.; 2025. 6. Zejula® (niraparib) [prescribing information]. Durham, NC: GlaxoSmithKline; 2026. 7. Keytruda® (pembrolizumab) [prescribing information]. Rahway, NJ: Merck & Co., Inc.;
- 8. Verzenio® (abemaciclib) [prescribing information]. Indianapolis, IN: Eli Lilly and Company; 2025.
This product information is intended for US healthcare professionals only.
LYNPARZA is a registered trademark of the AstraZeneca group of companies.
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US-112266 Last Updated 6/26
Posted Jul 9, 2026, 7:43 PM UTC · locked