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NOW APPROVED IN A NEW INDICATION: LYNPARZA is now available for patients with gBRCAm, HER2-negative metastatic breast cancer (mBC)
 
LYNPARZA™ (olaparib) logo
Dear Health Care Professional,
 
Based on new clinical data, you can now prescribe LYNPARZA, an oral therapy, for patients with deleterious or suspected deleterious gBRCAm, HER2-negative mBC who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with HR+ breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.1
 
gBRCAm tumor cells depend on PARP. Inhibit PARP with LYNPARZA1,4,5,†,‡
 
Designed for an unmet need: gBRCAm, HER2-negative mBC is a distinct form of breast cancer that most often occurs in patients with HER2-negative disease.6,7 Due to deficiencies in repairing DNA, gBRCAm tumor cells are especially reliant on PARP for survival.4,5 LYNPARZA is designed to disrupt the DNA repair process, which may help drive tumor cell death.1
 
Based on preclinical data.
The exact mechanism of action of LYNPARZA remains a subject of research.
LYNPARZA can also affect healthy cells.
 
LYNPARZA is a prescription oral treatment in the form of two 150 mg tablets, taken twice daily (300 mg per dose) with or without food.1
 
SELECT 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.
 
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.
 
Please see Important Safety Information.
 
  OlympiAD
(Tablets, 300 mg per dose, twice daily)1,8
 
  A phase 3, open-label, randomized, controlled, multicenter trial evaluating the efficacy and safety of olaparib monotherapy vs chemotherapy of health care provider's choice of capecitabine, eribulin, or vinorelbine in patients with gBRCAm, HER2-negative mBC, that was either HR+ or triple negative (N=302)1,8

Patients were randomized 2:1 to receive LYNPARZA or chemotherapy,§ and stratified based on hormone receptor status, prior chemotherapy for metastases, and prior platinum treatment1,8
 
 
LYNPARZA significantly improved
progression-free survival vs chemotherapy1,8,9,§
7.0 MONTHS
LYNPARZA
vs 4.2 MONTHS
CHEMOTHERAPY
42%
relative risk reduction
  HR=0.58
95% CI: 0.43-0.80; P=0.0009
Consistent results were observed across patient subgroups defined by
study stratification factors.1,||
LYNPARZA (n=167) more than doubled objective response rate
(52% vs 23%) compared with chemotherapy (n=66) with patients with measurable disease.1,§ Response based on confirmed responses. The confirmed complete response rate was 7.8% for LYNPARZA compared with 1.5% for the chemotherapy arm.1 Trial was not powered to assess statistical difference between treatment subgroups.8
The most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA tablets for gBRCAm, HER2-negative breast cancer were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%)
 
 
§ Chemotherapy of health care provider's choice included capecitabine, eribulin, or vinorelbine.1,8
|| An exploratory analysis of investigator-assessed PFS was consistent with the BICR-assessed PFS results.1
 
For more information on using LYNPARZA for your patients with gBRCAm, HER2-negative mBC who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting, please read:
 
 
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.
 
ADVERSE REACTIONS
 
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%).
 
DRUG INTERACTIONS
 
Anticancer Agents: Clinical studies of LYNPARZA in combination with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.
 
CYP3A Inhibitors: Avoid concomitant use of strong or moderate CYP3A inhibitors. If a strong or moderate CYP3A inhibitor must be co-administered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.
 
CYP3A Inducers: Avoid concomitant use of strong or moderate CYP3A inducers when using LYNPARZA. If a moderate inducer cannot be avoided, there is a potential for decreased efficacy of 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 hepatic impairment (Child-Pugh classification A). There are no data in patients with moderate or severe hepatic impairment.
 
Renal Impairment: No adjustment to the starting dose is necessary in patients with mild renal impairment (CLcr=51-80 mL/min). In patients with moderate renal impairment (CLcr=31-50 mL/min), reduce the dose 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 Patient Information (Medication Guide).
 
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
 
References: 1. Prescribing Information for LYNPARZA. AstraZeneca Pharmaceuticals LP, Wilmington, DE. 2. Zejula [full Prescribing Information]. Waltham, MA: TESARO, Inc; 2017. 3. Rubraca [full Prescribing Information]. Boulder, CO: Clovis Oncology, Inc; 2017. 4. Farmer H, McCabe N, Lord CJ, et al. Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy. Nature. 2005;434:917-921. 5. Bryant HE, Schultz N, Thomas HD, et al. Specific killing of BRCA2-deficient tumours with inhibitors of poly(ADP-ribose) polymerase. Nature. 2005;434:913-917. 6. Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106(5). doi:10.1093/jnci/dju055. 7. 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. 8. Robson M, Im S-A, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017;377(6):523-533. 9. Robson M, Im S-A, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation [supplementary appendix]. N Engl J Med. 2017;377(6):523-533.
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This product information is intended for US health care professionals only.
 
LYNPARZA is a registered trademark of the AstraZeneca group of companies.
 
The Information Center at AstraZeneca
1800 Concord Pike, PO Box 15437, Wilmington, DE 19850-5437
 
©2018 AstraZeneca. All rights reserved. US-17507 Last Updated 1/18
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