PATIENT ELIGIBILITY

LYNPARZA may be used as first-line treatment in eligible patients with g BRCAm,* HER2‐negative mBC if previously treated with chemotherapy in the neoadjuvant or adjuvant setting and endocrine therapy, if appropriate1

LYNPARZA® (olaparib) eligibility criteria
LYNPARZA® (olaparib) eligibility criteria

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Earliest eligibility for LYNPARZA1

FIRST-LINE METASTATIC if prior treatment occurred in the neoadjuvant or adjuvant setting

SECOND-LINE METASTATIC if prior treatment occurred in the metastatic setting

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

LYNPARZA patient case studies

Hillary, Age 50 Hillary, Age 50

*Not an actual patient.

Hillary, Age 50*

Medical History

  • Known family history of breast cancer
  • Initial diagnosis of HR+, HER2-negative stage IIA (T2N0M0) invasive ductal carcinoma of the breast
  • Hillary was tested for a gBRCA mutation at initial metastatic workup, in accordance with the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)2

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.

INITIAL TREATMENT

  • Lumpectomy with surgical axillary
    staging and radiation therapy
  • Standard adjuvant chemotherapy
  • Adjuvant endocrine therapy

11-MONTH DISEASE-FREE INTERVAL

NOW: CONFIRMED gBRCAm, HR+, HER2‐negative mBC

  • Confirmed liver nodules (<2 cm) and lung nodule (<1 cm)
  • ECOG score = 0
  • Laboratory values within normal range
  • Testing revealed a gBRCA mutation

Patients like Hillary with HR+ disease may eventually develop resistance to endocrine therapy.3

Would you consider LYNPARZA for Hillary’s first targeted treatment for her mBC?

Neoadjuvant or adjuvant anthracycline- and taxane-based therapies.

gBRCA=germline BRCA; HER2‐negative=human epidermal growth factor receptor 2 negative; HR=hormone receptor; mBC=metastatic breast cancer.

gBRCA=germline BRCA; HER2‐negative=human epidermal growth factor receptor 2 negative; HR=hormone receptor; mBC=metastatic breast cancer.

Tracy, Age 42

*Not an actual patient.

Tracy, Age 42*

Medical History

  • No known family history of breast cancer
  • Initial diagnosis of gBRCAm, triple-negative, stage IIB (T2N1M0) invasive ductal carcinoma of the breast
  • Tracy was tested for a gBRCA mutation, in accordance with the latest NCCN Guidelines®2

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.

INITIAL TREATMENT

  • Neoadjuvant chemotherapy
    • Treatment-related AR: alopecia
  • Bilateral mastectomy with surgical axillary staging and radiation therapy

1-YEAR DISEASE-FREE INTERVAL

NOW: CONFIRMED METASTATIC TNBC

  • Confirmed liver metastases (<2-cm nodules)
  • ECOG score = 0
  • Laboratory values within normal range

If another form of treatment is not used, patients with gBRCAm TNBC, like Tracy, may eventually be left with only chemotherapy as a treatment option.4

Would you consider LYNPARZA for Tracy’s first targeted treatment for her mBC?

Neoadjuvant or adjuvant anthracycline- and taxane-based therapies.

AR=adverse reaction; ECOG=Eastern Cooperative Oncology Group; gBRCAm=germline BRCA-mutated; HER2-negative=human epidermal growth factor receptor 2 negative; HR=hormone receptor; mBC=metastatic breast cancer.

AR=adverse reaction; ECOG=Eastern Cooperative Oncology Group; gBRCAm=germline BRCA-mutated; HER2-negative=human epidermal growth factor receptor 2 negative; HR=hormone receptor; mBC=metastatic breast cancer.

LYNPARZA patient case studies

Hillary, Age 50

*Not an actual patient.

Hillary, Age 50*

Medical History

  • Known family history of breast cancer
  • Initial diagnosis of HR+, HER2-negative stage IIA (T2N0M0) invasive ductal carcinoma of the breast
  • Hillary was tested for a gBRCA mutation at initial metastatic workup, in accordance with the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)2

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.

INITIAL TREATMENT

  • Lumpectomy with surgical axillary
    staging and radiation therapy
  • Standard adjuvant chemotherapy
  • Adjuvant endocrine therapy

11-MONTH DISEASE-FREE INTERVAL

NOW: CONFIRMED gBRCAm, HR+, HER2‐negative mBC

  • Confirmed liver nodules (<2 cm) and lung nodule (<1 cm)
  • ECOG score = 0
  • Laboratory values within normal range
  • Testing revealed a gBRCA mutation

Patients like Hillary with HR+ disease may eventually develop resistance to endocrine therapy.3

Would you consider LYNPARZA for Hillary’s first targeted treatment for her mBC?

Neoadjuvant or adjuvant anthracycline- and taxane-based therapies.

gBRCA=germline BRCA; HER2‐negative=human epidermal growth factor receptor 2-negative; HR=hormone receptor; mBC=metastatic breast cancer.

Tracy, Age 42

*Not an actual patient.

Tracy, Age 42*

Medical History

  • No known family history of breast cancer
  • Initial diagnosis of gBRCAm, triple-negative, stage IIB (T2N1M0) invasive ductal carcinoma of the breast
  • Tracy was tested for a gBRCA mutation, in accordance with the latest NCCN Guidelines®2

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.

INITIAL TREATMENT

  • Neoadjuvant chemotherapy
    • Treatment-related AR: alopecia
  • Bilateral mastectomy with surgical axillary staging and radiation therapy

1-YEAR DISEASE-FREE INTERVAL

NOW: CONFIRMED METASTATIC TNBC

  • Confirmed liver metastases (<2-cm nodules)
  • ECOG score = 0
  • Laboratory values within normal range

If another form of treatment is not used, patients with gBRCAm TNBC, like Tracy, may eventually be left with only chemotherapy as a treatment option.4

Would you consider LYNPARZA for Tracy’s first targeted treatment for her mBC?

Neoadjuvant or adjuvant anthracycline- and taxane-based therapies.

AR=adverse reaction; ECOG=Eastern Cooperative Oncology Group; gBRCAm=germline BRCA-mutated; HER2-negative=human epidermal growth factor receptor 2-negative; HR=hormone receptor; mBC=metastatic breast cancer.

LYNPARZA patient case studies

Hillary, Age 50

*Not an actual patient.

Medical History

  • Known family history of breast cancer
  • Initial diagnosis of HR+, HER2-negative stage IIA (T2N0M0) invasive ductal carcinoma of the breast
  • Hillary was tested for a gBRCA mutation at initial metastatic workup, in accordance with the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)2

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.

INITIAL TREATMENT

  • Lumpectomy with surgical axillary
    staging and radiation therapy
  • Standard adjuvant chemotherapy
  • Adjuvant endocrine therapy

11-MONTH DISEASE-FREE INTERVAL

NOW: CONFIRMED gBRCAm, HR+, HER2-negative mBC

  • Confirmed liver nodules (<2 cm) and lung nodule (<1 cm)
  • ECOG score = 0
  • Laboratory values within normal range
  • Testing revealed a gBRCA mutation

Patients like Hillary with HR+ disease may eventually develop resistance to endocrine therapy.3

Would you consider LYNPARZA for Hillary’s first targeted treatment for her mBC?

Neoadjuvant or adjuvant anthracycline- and taxane-based therapies.

gBRCA=germline BRCA; HER2‐negative=human epidermal growth factor receptor 2 negative; HR=hormone receptor; mBC=metastatic breast cancer.

gBRCA=germline BRCA; HER2-negative=human epidermal growth factor receptor 2-negative; HR=hormone receptor; mBC=metastatic breast cancer.

Tracy, Age 42

*Not an actual patient.

Medical History

  • No known family history of breast cancer
  • Initial diagnosis of gBRCAm, triple-negative, stage IIB (T2N1M0) invasive ductal carcinoma of the breast
  • Tracy was tested for a gBRCA mutation, in accordance with the latest NCCN Guidelines®2

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.

INITIAL TREATMENT

  • Neoadjuvant chemotherapy
    • Treatment-related AR: alopecia
  • Bilateral mastectomy with surgical axillary staging and radiation therapy

1-YEAR DISEASE-FREE INTERVAL

NOW: CONFIRMED METASTATIC TNBC

  • Confirmed liver metastases (<2-cm nodules)
  • ECOG score = 0
  • Laboratory values within normal range

If another form of treatment is not used, patients with gBRCAm TNBC, like Tracy, may eventually be left with only chemotherapy as a treatment option.4

Would you consider LYNPARZA for Tracy’s first targeted treatment for her mBC?

Neoadjuvant or adjuvant anthracycline- and taxane-based therapies.

AR=adverse reaction; ECOG=Eastern Cooperative Oncology Group; gBRCAm=germline BRCA-mutated; HER2-negative=human epidermal growth factor receptor 2-negative; HR=hormone receptor; mBC=metastatic breast cancer.

AR=adverse reaction; ECOG=Eastern Cooperative Oncology Group; gBRCAm=germline BRCA-mutated; HER2-negative=human epidermal growth factor receptor 2-negative; HR=hormone receptor; mBC=metastatic breast cancer.

IMPORTANT SAFETY INFORMATION

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:

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

Maintenance Recurrent Ovarian Cancer

For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

Advanced gBRCAm Ovarian Cancer

For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of 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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy, and some also had a history of more than one primary malignancy or of bone marrow dysplasia.

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 count 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: Occurred in <1% of patients exposed to LYNPARZA, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for 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.

Venous Thromboembolic Events: Including pulmonary embolism, occurred in 7% of patients with metastatic castration-resistant prostate cancer who received LYNPARZA plus androgen deprivation therapy (ADT) compared to 3.1% of patients receiving enzalutamide or abiraterone plus ADT in the PROfound study. Patients receiving LYNPARZA and ADT had a 6% incidence of pulmonary embolism compared to 0.8% of patients treated with ADT plus either enzalutamide or abiraterone. 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.

ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients in clinical trials of 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%), UTI (13%), thrombocytopenia (11%), and stomatitis (11%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of 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 compared to a ≥5% frequency for 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 thromboembolic events 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 Recurrent Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients in clinical trials of 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)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%) and dyspepsia (20%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA in the maintenance setting (SOLO-2/Study 19) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%).

ADVERSE REACTIONS—Advanced gBRCAm Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer after 3 or more lines of chemotherapy (pooled from 6 studies) were: fatigue/asthenia (66%), nausea (64%), vomiting (43%), anemia (34%), diarrhea (31%), nasopharyngitis/upper respiratory tract infection (URI) (26%), dyspepsia (25%), myalgia (22%), decreased appetite (22%), and arthralgia/musculoskeletal pain (21%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer (pooled from 6 studies) were: decrease in hemoglobin (90%), mean corpuscular volume elevation (57%), decrease in lymphocytes (56%), increase in serum creatinine (30%), decrease in platelets (30%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients in 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 in 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 (Grades 1-4) in ≥10% of patients in clinical trials of 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 in clinical trials of 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 in clinical trials of 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 in clinical trials of LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

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).

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