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The following information helps you to find FDA Alerts and Pharmacist’s Applications to Practice quickly and easily. In cooperation with the Food and Drug Administration (FDA), and as a service to our members, HOPA periodically distributes information about newly approved therapies for cancer patients from FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur to inform oncologists and professionals in oncology-related fields in a timely manner. Links to product labels will take you to relevant clinical information on the indication, contraindications, dosing, and safety. In sending this information, HOPA does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.

Along with HOPA’s Publications Committee, members also review new drug updates and provide analysis and research on the application of these new drugs or indications. Pharmacist’s Applications to Practice, or PAP, are listed after drugs that include the additional analysis. If you are interested in helping the Publications Committee with creating a Pharmacist's Application to Practice, please contact Jeff Price at jprice@hoparx.org.

You can also find additional information on FDA Alerts and Updates by listening to FDA Drug Safety Podcasts.


December 19, 2018–Olaparib for first-line maintenance of BRCA-mutated advanced ovarian cancer

January 12, 2018–Olaparib tablets (Lynparza®, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, approved for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting.(with Pharmacist's Applications to Practice.)

August 17, 2017–Olaparib tablets (Lynparza®, AstraZeneca) approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy (with Pharmacist's Applications to Practice.)


December 19, 2018

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s006lbl.pdf.

On December 19, 2018, the Food and Drug Administration approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP) 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. Patients with gBRCAm advanced epithelial ovarian, fallopian tube or primary peritoneal cancer should be selected for therapy based on an FDA-approved companion diagnostic.

Approval was based on SOLO-1 (NCT01844986), a randomized, double-blind, placebo-controlled, multi-center trial that compared the efficacy of olaparib with placebo in patients with BRCA-mutated (BRCAm) advanced ovarian, fallopian tube, or primary peritoneal cancer following first-line platinum-based chemotherapy. Patients were randomized (2:1) to receive olaparib tablets 300 mg orally twice daily (n=260) or placebo (n=131).

The primary efficacy outcome was investigator-assessed progression-free survival (PFS) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The trial demonstrated a statistically significant improvement in investigator-assessed PFS for olaparib compared to placebo. Estimated median PFS was not reached in the olaparib arm and was 13.8 months in the placebo arm (HR 0.30; 95% CI: 0.23-0.41; p<0.0001). At the time of the analysis of PFS, overall survival data were not mature.

Most common (≥10%) adverse reactions of any grade occurring in patients who received olaparib in SOLO-1 were nausea, fatigue, abdominal pain, vomiting, anemia, diarrhea, upper respiratory tract infection/influenza/nasopharyngitis/bronchitis, constipation, dysgeusia, decreased appetite, dizziness, neutropenia, dyspepsia, dyspnea, urinary tract infection (UTI), leukopenia, thrombocytopenia, and stomatitis.

FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) to identify patients with germline BRCA mutated (gBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are eligible for olaparib. The effectiveness of the BRACAnalysis CDx test was based on the SOLO-1 trial population for whom deleterious or suspected deleterious gBRCAm status was confirmed with either prospective or retrospective testing with the BRACAnalysis CDx test.

The recommended olaparib dose is 300 mg (two 150 mg tablets) taken orally twice daily, with or without food, for a total daily dose of 600 mg.

View full prescribing information for LYNPARZA.

The FDA Oncology Center of Excellence Assessment Aid Pilot Project was used for the review of this application.

FDA granted this application priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.


January 12, 2018, with PAP

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s001lbl.pdf

On January 12, 2018, the Food and Drug Administration granted regular approval to olaparib tablets (Lynparza®, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting.

This is the first FDA-approved treatment for patients with gBRCAm HER2-negative metastatic breast cancer. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. Patients must be selected for therapy based on an FDA-approved companion diagnostic for olaparib.

Approval was based on data from OlympiAD (NCT02000622), an open-label, multi-center clinical trial that randomized 302 patients with gBRCAm, HER2-negative metastatic breast cancer (2:1) to olaparib 300 mg orally twice daily or physician’s choice of chemotherapy (capecitabine, vinorelbine, or eribulin). All patients had to have a known deleterious or suspected deleterious gBRCA mutation and must have received prior chemotherapy in the neoadjuvant, adjuvant, or metastatic setting to be randomized. Randomization was stratified by prior use of chemotherapy for metastatic disease, hormone receptor status (hormone receptor-positive vs. triple-negative), and previous use of platinum-based chemotherapy. The primary efficacy outcome was progression-free survival (PFS) assessed by blinded independent central review (BICR). Estimated median PFS was 7.0 and 4.2 months in the olaparib and chemotherapy arms, respectively (HR 0.58, 95% CI: 0.43, 0.80; p=0.0009).

The most common adverse reactions reported in at least 20% of patients taking olaparib in clinical trials were anemia, nausea, fatigue (including asthenia), vomiting, neutropenia, leukopenia, nasopharyngitis/upper respiratory tract infection/influenza, respiratory tract infection, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, and stomatitis

FDA also granted marketing authorization for the BRACAnalysis CDx® test (Myriad Genetic Laboratories, Inc.) for use as an aid in identifying patients with breast cancer with deleterious or suspected deleterious gBRCAm who may be eligible for olaparib. The effectiveness of the BRACAnalysis CDx® test was established based on the OlympiAD trial population for whom deleterious or suspected deleterious gBRCAm status was confirmed with prospective or retrospective testing with the BRACAnalysis CDx® test.

The recommended dose of olaparib is 300 mg (two 150 mg tablets) taken orally twice daily with or without food. Full prescribing information is available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s001lbl.pdf

FDA granted priority review to olaparib for this application. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).


Pharmacist's Applications to Practice

Olaparib  Tablets for the Treatment of Germline BRCA-Mutated, Human Epidermal Growth Factor Receptor Type 2 (HER-2) Negative Metastatic Breast Cancer

Author: Mona Benrashid, PharmD BCOP
Clinical Pharmacist, Breast Medical Oncology
Vanderbilt University Medical Center
Nashville, TN

What is the potential role for olaparib in the treatment of metastatic breast cancer (MBC)?1-6

  • Olaparib is a poly(adenosine diphosphate–ribose) polymerase (PARP) inhibitor approved by the U.S. Food and Drug Administration (FDA) in January 2018 for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor type 2 (HER2)–negative metastatic breast cancer (MBC) who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. Hormone receptor (HR)–positive patients should be ineligible for endocrine treatment or have received prior endocrine treatment.
  • Approval was based on the results from the prospective randomized open-label phase 3, OlympiAD trial in patients with gBRCAm HER-2 negative MBC who had received no more than two previous chemotherapy regimens for metastatic disease.
    • Treatment with olaparib was associated with an improved median progression-free survival (PFS) of 7 months versus 4.2 months when compared to physician’s choice single-agent chemotherapy (capecitabine, eribulin, or vinorelbine).
  • Olaparib is the only PARP inhibitor approved for the management of MBC; however, three commercially available PARP inhibitors have been approved for the management of ovarian cancer: niraparib, rucaparib and olaparib.
    • Niraparib is also approved for use in fallopian tube and primary peritoneal cancer.
  • The National Comprehensive Cancer Network (NCCN) lists olaparib as a preferred single agent in the management of HER-2 negative recurrent breast cancer or MBC in the presence of a gBRCAm.

What role can the pharmacist play in the management of patients on olaparib? 3,7

  • Pharmacists need to be aware of the variation in olaparib dosing and dosage forms by indication. Because of differences in bioavailability, olaparib tablets and capsules should not be substituted on a mg-by-mg basis.
    • When used for treating metastatic breast cancer, olaparib tablets are dosed at 300 mg by mouth twice daily until disease progression or unacceptable toxicity.
  • Olaparib is primarily metabolized by cytochrome P450 3A4 (CYP3A4). Patients should be screened for concomitant use of CYP3A4 inhibitors and inducers.
    • If use of moderate CYP3A4 inhibitor cannot be avoided, a dose reduction of olaparib to 150 mg twice daily is recommended.
    • If use of strong CYP3A4 inhibitor cannot be avoided, a dose reduction of olaparib to 100 mg twice daily is recommended.
  • The olaparib dose should be reduced to 200 mg twice daily in patients with moderate renal impairment, defined as creatinine clearance (CrCl) 31–50 ml/min.
  • No olaparib dose adjustment is required in mild hepatic impairment (Child-Pugh class A). Olaparib has not been studied in patients with moderate-to-severe hepatic impairment (Child-Pugh classes B and C).
  • Most common adverse reactions in OlympiAD were nausea (58%), anemia (all grades: 40%; grade 3 or greater: 16.1%), vomiting (29.8%), fatigue (28.8%), neutropenia (27.3%; grade 3 or greater: 9.3%), respiratory tract infection (27%), leukopenia (25%), diarrhea (20.5%), and headache (20%).
    • The most common adverse reactions are similar across breast and ovarian cancer patients.
  • Olaparib may be dose reduced for toxicity. The recommended first olaparib dose reduction is to 250 mg twice daily. If further reduction required, reduce the olaparib dose to 200 mg twice daily.
  • Patients should be counseled to take olaparib twice daily with or without food.
  • The Lynparza Patient Savings Program (https://www.astrazenecaspecialtysavings.com/content/dam/website-services/us/375-rwd-affordability-com/pdf/LYNPARZA_Affordability_Brochure.pdf) is available for patients with commercial insurance. Most eligible patients will pay $0 per month and may have access to up to $26,000 per year to assist with Lynparza out-of-pocket costs. The AstraZeneca Access 360 Program may have resources for patients ineligible for the Lynparza Patient Savings Program.

Clinical Pearls 1-3,8,9

  • Olaparib is supplied as 100 mg and 150 mg tablets. Olaparib 50 mg capsules should not be used for the treatment of MBC.
  • Patients should be educated on the management of nausea and vomiting because these are common adverse events.
    • The NCCN Antiemesis Guidelines classify olaparib as having moderate to high emetogenic potential; routine prophylaxis is recommended.
  • A complete blood count (CBC) should be obtained at baseline and monthly thereafter. Renal function should also be monitored during treatment.
    • Olaparib should be withheld in the setting of prolonged hematologic toxicity, and CBC should be monitored weekly.
  • Monitor for signs and symptoms of pneumonitis, which has been reported in less than 1% of patients treated with olaparib.
    • Olaparib should be permanently discontinued in the setting of pneumonitis.
  • Monitor for signs and symptoms of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), which have been reported in patients treated with olaparib.
    • Further evaluation is warranted in the setting of prolonged hematologic toxicity if blood counts do not recover to grade 1 or less after 4 weeks.
    • Olaparib should be permanently discontinued in the setting of confirmed MDS or AML.
  • The OlympiAD trial also established the efficacy of the BRACAnalysis CDx® test, resulting in FDA approval of the BRACAnalysis CDx® test for identifying patients with MBC with deleterious or suspected deleterious gBRCAm who may be eligible for olaparib.

References

  1. U.S. Food and Drug Administration: Approved Drugs. FDA approves olaparib for germline BRCA-mutated metastatic breast cancer. January 12, 2018. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm592357.htm. Accessed February 28, 2018.
  2. Robson M, Im SA, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017;377:523-533.
  3. Lynparza (olaparib) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; January 2018.
  4. Zejula (niraparib) [package insert]. Waltham, MA: Tesaro Inc.; August 2017.
  5. Rubraca (rucaparib) [package insert]. Boulder, CO: Clovis Oncology, Inc.; December 2016.
  6. National Comprehensive Cancer Network. Breast Cancer. Version 4.2017. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed February 28, 2018.
  7. Pujade-Lauraine E, Ledermann JA, Selle F, et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2.
  8. National Comprehensive Cancer Network. Antiemesis. Version 1.2018. https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed February 28, 2018.
  9. Myriad Genetics, Inc. BRACAnalysis CDx. https://myriad.com/products-services/companion-diagnostics/bracanalysis-cdx/

August 17, 2017, with PAP

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf

On Aug. 17, 2017, the U.S. Food and Drug Administration granted regular approval to olaparib tablets (Lynparza®, AstraZeneca) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.

With the addition of the new indication, a tablet formulation of olaparib is introduced. FDA approved olaparib capsules in 2014 for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Today, FDA also approved olaparib tablets for this indication. Olaparib tablets and capsules are not interchangeable. Olaparib capsules are being phased out of the U.S. market and will be available only through the Lynparza Specialty Pharmacy Network.

The approval in the maintenance setting was based on two randomized, placebo-controlled, double-blind, multicenter trials in patients with recurrent ovarian cancers who were in response to platinum-based therapy.

SOLO-2 (NCT01874353) randomized 295 patients with recurrent germline BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer (2:1) to receive olaparib tablets 300 mg orally twice daily or placebo. SOLO-2 demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS) in patients randomized to olaparib compared with those who received placebo, with a hazard ratio (HR) of 0.30 (95% CI: 0.22, 0.41; p<0.0001). The estimated median PFS was 19.1 and 5.5 months in the olaparib and placebo arms, respectively.

Study 19 (NCT00753545) randomized 265 patients regardless of BRCA status (1:1) to receive olaparib capsules 400 mg orally twice daily or placebo. Study 19 demonstrated a statistically significant improvement in investigator-assessed PFS in patients treated with olaparib vs. placebo with a HR of 0.35 (95% CI: 0.25, 0.49; p<0.0001). The estimated median PFS was 8.4 months and 4.8 months in the olaparib and placebo arms, respectively.

The most common adverse reactions (≥20%) in clinical trials were anemia, nausea, fatigue (including asthenia), vomiting, nasopharyngitis, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, and stomatitis. The most common laboratory abnormalities (≥25%) were decrease in hemoglobin, increase in mean corpuscular volume, decrease in lymphocytes, decrease in leukocytes, decrease in absolute neutrophil count, increase in serum creatinine, and decrease in platelets.

The recommended olaparib tablet dose for both the maintenance therapy and later line treatment setting is 300 mg (two 150 mg tablets) taken orally twice daily with or without food.

Full prescribing information is available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf.

FDA granted this application Fast Track status. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at:
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).


Pharmacist’s Applications to Practice

Olaparib Tablets for Maintenance Treatment of Adult Patients with Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, Who Are in a Complete or Partial Response to Platinum-Based Chemotherapy

Author: Melissa Gamble, PharmD Candidate
University of Colorado
Aurora, CO

What is the potential role for olaparib for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers?1-4

  • The current standard-of-care maintenance therapy for patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers includes bevacizumab or niraparib.
    • Both agents had an improved progression-free survival (PFS).
      • bevacizumab: OCEANS trial (12 months vs. 8 months, hazard ratio [HR] .48) and Gynecologic Oncology Group (GOG) 213 trial (14 months vs. 10 months, HR .61). There was a trend toward improved median overall survival (OS) with bevacizumab (43 months vs. 37 months, respectively; HR .82, 95% confidence interval [CI] .68-.996).
      • niraparib: NOVA study (gBRCA group: 21 months vs. 5.5 months, HR .27; overall non-gBRCA cohort: 9.3 months vs. 3.9 months, HR .45). OS results are pending.
  • Olaparib is a new treatment option for maintenance therapy in patients with complete or partial response to platinum-based chemotherapy.
    • SOLO-2: Patients with a BRCA mutation had a longer PFS (19.1 months vs. 5.5 months; HR .30).
    • Study 19: Patients with a BRCA mutation had a longer PFS benefit than those without the mutation (BRCA mutation group: 11 months vs. 4 months; HR .18; BRCA non-mutation group: 7 months vs. 5.5 months; HR .54). However, olaparib has shown improvement in PFS in both patient populations (all patients regardless of BRCA status: 8.4 months vs. 4.8 months; HR .35).
    • Additionally, median OS after more than 5 years of total follow-up was 29.8 months vs. 27.8 months with placebo (HR 73; 95% CI .55-.96).
  • Olaparib has not been compared directly to other maintenance treatment options, including bevacizumab and niraparib.
  • Olaparib has shown a low rate of serious toxicities (grade 3-4) in patients with platinum-sensitive disease (35.3% in the olaparib group and 20.3% in the placebo group).

What role can the pharmacist play in the management of patients on olaparib?5-7

  • Olaparib is an orally administered product; the pharmacist therefore plays an important role in maintaining adherence to therapy by helping with access to medication, counseling, and side-effect management.
  • Olaparib is renally excreted and should be dose adjusted for patients with a CrCl of 31–50 ml/min. Olaparib use in patients with a CrCl of 30 ml/min or less has not been studied.
  • Olaparib is a major CYP3A4 substrate. Use with strong or moderate CYP3A inhibitors or inducers should be avoided. If use with CYP3A inhibitors cannot be avoided, dose adjustment is warranted. If use with CYP3A inducers cannot be avoided, monitoring for efficacy is warranted.
    • Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during treatment.
  • Olaparib can cause bone marrow suppression, including decreased hemoglobin (85%–90%; grades 3/4: 8%–15%), decreased absolute lymphocyte count (56%; grades 3/4: 17%), anemia (25%–34%; grades 3/4: 4%–18%), decreased neutrophils (25%–32%; grades 3/4: 7%–8%), decreased platelet count (26%–30%; grades 3/4: 3%–6%). Monitor a complete blood count at baseline and monthly thereafter.
    • Serious side effects include fatalities related to the development of myelodysplastic syndrome or acute myeloid leukemia (less than 1.5%) and pneumonitis (less than 1%).
  • Olaparib has a moderate-to-high emetic risk. Prophylaxis with single-agent antiemetic therapy, such as an oral 5-HT3 antagonist, is recommended.

Clinical Pearls5,6

  • Olaparib is available as 100-mg and 150-mg tablets and as 50-mg capsules. Do not substitute olaparib tablets with olaparib capsules on a mg-to-mg basis because of differences in the dosing and bioavailability of each formulation. The tablet formulation features improved bioavailability and was developed with the intent to substantially reduce pill burden from 16 capsules per day to 4 tablets daily.
    • Only the tablet formulation of olaparib is indicated for maintenance therapy of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are in a complete or partial response following platinum-based chemotherapy.
      • Dosing (tablet): 300 mg (two 150-mg tablets) twice daily (every 12 hours) until disease progression or unacceptable toxicity.
    • Both capsules and tablets are indicated for use in the treatment of advanced ovarian cancer in patients with the BRCA mutation and three or more prior lines of chemotherapy.
      • Dosing (capsule): 400 mg (eight 50-mg capsules) twice daily (every 12 hours) until disease progression or unacceptable toxicity
      • Dosing (tablet): 300 mg (two 150-mg tablets) twice daily (every 12 hours) until disease progression or unacceptable toxicity
  • The average wholesale price (AWP) of one 150-mg tablet is $134.82. The estimated AWP for 1 month of therapy is $16,178.40. Financial assistance is available to eligible commercially insured patients through the AstraZeneca support program, Access 360.
  • Olaparib is not on the 2016 National Institute for Occupational Safety and Health list. However, single gloving is recommended during receiving, handling, administration, and disposal of this agent.

References

  1. Coleman RL, Sabbatini P. Medical treatment for relapsed epithelial ovarian, fallopian tubal, or peritoneal cancer: Platinum-sensitive disease. UpToDate. Waltham, MA: UpToDate; 2017. Accessed September 9, 2017.
  2. Pujade-Lauraine E, Ledermann JA, Selle F, et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2.
  3. Ledermann JA, Harter P, Gourley C, et al. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol. 2016;17(11):1579-1589.
  4. National Comprehensive Cancer Network. Ovarian Cancer. Version 3.2017. Available at: https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed September 9, 2017.
  5. Lynparza [package insert]. AstraZeneca Pharmaceuticals LP, Wilmington, DE; August 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf. Accessed September 9, 2017.
  6. Lexi-Drugs Online, Hudson, OH: Lexi-Comp, Inc.; 2017; Accessed September 9, 2017.
  7. National Comprehensive Cancer Network. Antiemesis. Version 2.2017. Available at: https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed September 9, 2017.
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