This article is sponsored by AstraZeneca.

As a medical professional and oncologist, personalized and compassionate care has been a core pillar of my approach. I learned early in my medical training how important understanding the whole patient can be to best support people facing cancer, especially when it comes to potential treatment options and health-related quality of life.

Outside the clinic, I also have first-hand experience of what a cancer diagnosis means to a family. My mother was diagnosed with breast cancer, and both of us played an active role in advocating for testing and defining her course of treatment.

I share this because we know that no two breast cancer diagnoses are the same. Innovations are happening at a rapid pace, and considering an individual’s unique needs and the specific qualities of their cancer has the potential to make a truly meaningful impact on their outcomes.

Considering the Whole Person in Breast Cancer Care

When a patient presents with abnormal findings from laboratory work or imaging studies, they bring more than their test results into the consultation room. They arrive with complex medical histories alongside robust lifestyles, active careers, family responsibilities, and individual circumstances that directly impact treatment decisions and outcomes. Many patients enter this conversation already anxious and overwhelmed by preliminary online research.

My job in this reality for so many patients is to share that breast cancer is not one-size-fits all, and the experience of family, friends, and online profiles is not always the same as how we may approach this cancer diagnosis.

We first have to understand some key qualities of a person’s breast cancer, such as stage of disease, tumor biology, and patient factors like age, menopausal status, and maternal and paternal family histories of cancer. One of the most important things any oncologist can do, whether a community generalist or breast cancer specialist, is recommend appropriate patients get tested for germline genetic and tumor mutations.

Finding Our Targets

While patients can sometimes view a germline genetic mutation as a defect, I see it as something to work with, a target that, along with the patient’s personal priorities and values, can help us begin tailoring treatment.

For example, mutated or altered BRCA1 or BRCA2 genes mean DNA damage may not be repaired properly. As a result, unstable cells are more likely to develop additional genetic alterations that can lead to certain types of cancer.^1-3 Because germline mutations in BRCA1 and BRCA2 genes account for up to 10 percent of all breast cancer cases,​⁴ offering genetic testing to my patients is a priority for me.

Experts agree. The American Society of Breast Surgeons (ASBRS) Consensus Guideline on Genetic Testing for Hereditary Breast Cancer recommends genetic testing be made available to all patients with a personal history of breast cancer to assess hereditary risk and identify targeted treatment options.⁵ When I talk to colleagues about why I prioritize germline BRCA testing, I point to the numbers. Approximately 1 in 10 patients with HER2-negative breast cancer has a germline BRCA mutation (gBRCAm).^6,7,8-11 When we look at the full picture, the majority of patients with gBRCAm HER2-negative breast cancer actually have HR-positive disease.^6,7 That realization changed how I think about testing.

Identifying a gBRCAm can help inform treatment options.⁵ LYNPARZA® (olaparib) tablets are a PARP inhibitor that is approved by the FDA for certain eligible patients with gBRCAm, HER2-negative, high-risk early breast cancer and gBRCAm, HER2-negative metastatic breast cancer. In the adjuvant setting, treatment consists of one year of LYNPARZA following neoadjuvant or adjuvant chemotherapy.¹³ OlympiA and OlympiAD were Phase III trials that demonstrated statistically significant improvements in their respective primary endpoints with LYNPARZA treatment.¹³ In the OlympiA trial, LYNPARZA demonstrated statistically significant improvement compared to placebo in invasive disease-free survival (IDFS), the primary endpoint, in certain patients with gBRCAm, HER2-negative, high-risk early breast cancer (HR=0.58 [95% CI: 0.46–0.74]; P<0.0001). Overall survival, a key secondary endpoint, was also significantly improved (HR=0.68 [95%: 0.50-0.91]; P=0.0091). In the OlympiAD trial, LYNPARZA significantly improved progression free-survival (PFS) compared to physician’s choice of chemotherapy in certain patients with gBRCAm, HER2-negative metastatic breast cancer with median progression-free survival of 7.0 months with LYNPARZA vs 4.2 months with physician’s choice of chemotherapy (HR=0.58 [95% CI: 0.43–0.80]; P=0.0009).¹³

Olaparib is a poly (ADP-ribose) polymerase inhibitor (PARPi) recommended as an NCCN Category 1 preferred regimen in both the adjuvant and metastatic breast cancer settings in eligible patients.¹⁴ ​Importantly, LYNPARZA is the only targeted adjuvant therapy to demonstrate a significant improvement in invasive disease-free survival and an overall survival benefit versus placebo specifically in patients with gBRCAm, HER2-negative, high-risk early breast cancer.¹³ In these patients, the OlympiA trial demonstrated that LYNPARZA reduced the risk of invasive disease recurrence or death by 42% (HR=0.58; 95% CI, 0.46–0.74; P<0.0001) and the risk of death by 32% versus placebo (HR=0.68; 95% CI, 0.50–0.91; P=0.0091), with six-year OlympiA follow up data available.¹³

In my experience, LYNPARZA has a demonstrated benefit-risk profile, well-characterized safety profile, and, as an oral medicine, the administration is convenient for many patients I work with. A defined treatment course matters.

Testing for a BRCA mutation is less expensive and more accessible than it was when testing became available for clinical use more than two decades ago.¹⁵ Increased awareness and access to genetic testing can expand treatment options for eligible patients and provide important information about familial cancer risks, but this requires engagement from us, the providers, and patients.​^1,13 It’s the first important step in identifying patients with breast cancer who have gBRCAm, which has emerged as a distinct disease driver for early and metastatic breast cancer.​¹⁶

Indications

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 this indication based on an FDA-approved companion diagnostic for LYNPARZA.

LYNPARZA is indicated for the treatment of patients with gBRCAm,* HER2-negative metastatic breast cancer after receiving chemotherapy in the neoadjuvant, adjuvant, or metastatic setting and endocrine therapy, if appropriate.

*Select patients for this indication based on an FDA-approved companion diagnostic for LYNPARZA.

Select Safety Information for LYNPARZA

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 the complete Important Safety Information below and complete Prescribing Information, including Medication Guide.

Making Decisions with Patients

In my experience, individualized treatment goes beyond targeting cancer with medicine. I try to understand patients’ unique circumstances through the right conversations.

Certain racial and ethnic backgrounds, like individuals with Ashkenazi Jewish ancestry, are more likely to have gBRCAm, which brings that discussion to the forefront.¹ Family history is important, but many patients may not know their family history. This could be because of adoption or estrangement, among a variety of other reasons.¹⁵ There are lifestyle factors to consider, such as what side effects might be more tolerable for a young mom or which medication administration will be most convenient for someone who often travels for work. And I discuss clinical trials with patients regardless of their disease stage. If they’re the right fit for a study, I want to help them understand the pros and cons of their potential participation.

Today’s patients are often armed with AI-generated questions or information. While properly sourced AI can be helpful, I don’t view it as a substitute for patient-doctor discussions. I bring it back to the fundamentals. We’re going to work together to treat your specific cancer step-by-step.

Talk to your patients about genetic and tumor testing. This knowledge is critical for informing treatment decisions and can be empowering for them.

For more information about OlympiA and OlympiAD data and potential treatment options for certain types of breast cancer, please visit https://www.lynparzahcp.com/breast-cancer/home.html.

My Approach to Harnessing the Power of Personalized Care

• Early genetic testing: Identifying BRCA1/BRCA2 mutations early after diagnosis can guide treatment decisions/options (surgery and systemic treatment). There’s evidence that PARP inhibitors, such as LYNPARZA, could be appropriate for eligible patients. I also make sure to consult other experts as needed and I encourage others to do so, too.
• Personalization: I want to ensure I’m meeting patients where their knowledge, priorities and cultural backgrounds are. I encourage questions, foster dialogue and recommend additional opinions.
• Staying current: Guidelines change rapidly, so I stay on top of what to test, how to treat and which questions to ask.

Kelly E. McCann, MD, PhD is a board-certified hematologist-oncologist and associate clinical professor in the division of hematology/oncology at the Moores Cancer Center at UC San Diego. She is a paid consultant for AstraZeneca. All opinions expressed are those of the health care provider.

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.

In SOLO-1, patients with newly diagnosed advanced BRCAm ovarian cancer, the incidence of MDS/AML was 1.9% (5/260) in patients who received LYNPARZA and 0.8% (1/130) in patients who received placebo based on an updated analysis. In PAOLA-1, of patients with newly diagnosed advanced ovarian cancer with HRD-positive status, the incidence of MDS/AML was 1.6% (4/255) in patients who received LYNPARZA and 2.3% (3/131) in the control arm.

In SOLO-2, patients with BRCAm platinum-sensitive relapsed ovarian cancer, the incidence of MDS/AML was 8% (15/195) in patients who received LYNPARZA and 4% (4/99) in patients who received placebo. The duration of LYNPARZA treatment prior to the diagnosis of MDS/AML ranged from 0.6 years to 4.5 years.

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. In the combined data of two randomized, placebo-controlled clinical studies (PROfound and PROpel) in patients with metastatic castration-resistant prostate cancer (N=1180), VTE occurred in 8% of patients who received LYNPARZA, including pulmonary embolism in 6%. In the control arms, VTE occurred in 2.5%, including pulmonary embolism in 1.5%. 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—First-Line Maintenance BRCAm Advanced Ovarian Cancer

Most common adverse reactions (all Grades) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), urinary tract infection (13%), thrombocytopenia (11%), and stomatitis (11%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).

ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

Most common adverse reactions (Grades 1-4) in ≥10% of patients treated with LYNPARZA/bevacizumab and at a ≥5% frequency compared to placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%), and leukopenia (18%). In addition, the most common adverse reactions (≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%), and headache (14%).

In addition, venous thromboembolism occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%), and decrease in platelets (35%).

ADVERSE REACTIONS—Maintenance gBRCAm Recurrent Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/sinusitis/rhinitis/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the maintenance setting for SOLO-2 were: increase in mean corpuscular volume (89%), decrease in hemoglobin (83%), decrease in leukocytes (69%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), increase in serum creatinine (44%), and decrease in platelets (42%).

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%).

ADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).

ADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic Pancreatic Adenocarcinoma

Most common adverse reactions (all Grades) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA for PROfound were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

ADVERSE REACTIONS—Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA/abiraterone with a difference of ≥5% compared to placebo/abiraterone for PROpel were: anemia (48%), fatigue (including asthenia) (38%), nausea (30%), diarrhea (19%), decreased appetite (16%), lymphopenia (14%), dizziness (14%), and abdominal pain (13%).

Most common laboratory abnormalities (Grades 1-4) in ≥20% of patients who received LYNPARZA/abiraterone for PROpel were: decrease in hemoglobin (97%), decrease in lymphocytes (70%), decrease in platelets (23%), and decrease in absolute neutrophil count (23%).

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).

INDICATIONS

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

First-Line Maintenance BRCAm Advanced Ovarian Cancer
For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) 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.

First-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab

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.

Maintenance BRCA-mutated Recurrent Ovarian Cancer
For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) 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.

Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early 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.

gBRCAm, HER2-Negative Metastatic Breast Cancer
For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (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.

First-Line Maintenance gBRCAm Metastatic 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.

HRR Gene-mutated Metastatic Castration-Resistant 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.

BRCAm Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone
In combination with abiraterone and prednisone or prednisolone (abi/pred) 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.

Please see complete Prescribing Information, including Medication Guide.

LYNPARZA is a registered trademark of the AstraZeneca group of companies.

References

1. National Institutes of Health. National Cancer Institute. BRCA Gene Changes. Cancer Risk and Genetic Testing. Accessed May 2026. https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet.

2. Wu J, Lu LY, Yu X. The role of BRCA1 in DNA damage response. Protein Cell. 2010;1(2):117-123.

3. Gorodetska I, Kozeretska I, Dubrovska A. BRCA Genes: The Role in Genome Stability, Cancer Stemness and Therapy Resistance. J Cancer. 2019;10:2109-2127.

4. Godet I, Gilkes DM. BRCA1 and BRCA2 mutations and treatment strategies for breast cancer. Integr Cancer Sci Ther. 2017;4(1):10.15761/ICST.1000228.

5. Manahan ER, Kuerer HM, Sebastian M, et al. Consensus Guidelines on Genetic Testing for Hereditary Breast Cancer from the American Society of Breast Surgeons. Ann Surg Oncol. 2019;26(10):3025-3031. doi:10.1245/s10434-019-07549-8.

6. Kurian AW, Ward KC, Howlader N, et al. Genetic testing and results in a population-based cohort of breast cancer patients and ovarian cancer patients. Supplementary material. Table S3: genetic test results by breast cancer biomarker subtypes among breast cancer patients. J Clin Oncol. 2019;37(15):1305-1315.

7. O’Shaughnessy J, Brezden-Masley C, Cazzaniga M, et al. Prevalence of germline BRCA mutations in HER2-negative metastatic breast cancer: global results from the real-world, observational BREAKOUT study. Breast Cancer Res. 2020;22(1):114.

8. Winter C, Nilsson MP, Olsson E, et al. Targeted sequencing of BRCA1 and BRCA2 across a large unselected breast cancer cohort suggests that one-third of mutations are somatic. Supplementary material. Table S4: BRCA status and clinical characteristics. Ann Oncol. 2016;27(8):1532-1538.

9. Copson ER, Maishman TC, Tapper WJ, et al. Germline BRCA mutation and outcome in young-onset breast cancer (POSH): a prospective cohort study. Lancet Oncol. 2018;19(2):169-180.

10. Kim H, Choi DH, Park W. Germline BRCA mutation and clinical outcomes in breast cancer patients focusing on survival and failure patterns: a long-term follow-up study of Koreans. Medicina (Kaunas). 2020;56(10):514.

11. Tung N, Lin NU, Kidd J, et al. Frequency of germline mutations in 25 cancer susceptibility genes in a sequential series of patients with breast cancer. J Clin Oncol. 2016;34(13):1460-1468.

12. Hu C, Polley EC, Yadav S, et al. The contribution of germline predisposition gene mutations to clinical subtypes of invasive breast cancer from a clinical genetic testing cohort. J Natl Cancer Inst. 2020;112(12):1231-1241.

13. LYNPARZA® (olaparib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025.

14. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Breast Cancer V.6.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed July 30, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

15. Toland AE, Forman A, Couch FJ, et al. Clinical testing of BRCA1 and BRCA2: a worldwide snapshot of technological practices. NPJ Genom Med. 2018;3:7. doi:10.1038/s41525-018-0046-7.

16. Arun B, Couch FJ, Abraham J, et al. BRCA-mutated breast cancer: the unmet need, challenges and therapeutic benefits of genetic testing. Br J Cancer. 2024;131(9):1400-1414.

US-114068 Last Updated 9/26