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    Association details:
    Biomarker:BRCA2 mutation
    Cancer:Peritoneal Cancer
    Drug:Lynparza (olaparib) (PARP inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    AstraZeneca Press Release
    Title:

    Lynparza approved in China as a 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer

    Published date:
    12/05/2019
    Excerpt:
    AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the companies have received marketing authorisation from China’s National Medical Products Administration (NMPA) for Lynparza (olaparib) as a 1st-line maintenance treatment of adult patients with newly diagnosed advanced germline or somatic BRCA mutated (gBRCAm or sBRCAm) epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Therapeutic Goods Administration
    Published date:
    12/05/2018
    Excerpt:
    AusPAR...Olaparib is indicated as monotherapy for the maintenance treatment of patients with platinum-sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) after platinum-based chemotherapy.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    AstraZeneca Press Release
    Title:

    Health Canada approves LYNPARZA for the Treatment of Ovarian Cancer with BRCA-Mutations

    Published date:
    05/03/2016
    Excerpt:
    AstraZeneca Canada announced today that Health Canada has approved LYNPARZA (olaparib) capsules as a maintenance treatment for patients with platinum-sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer.
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    European Medicines Agency
    Excerpt:
    Lynparza is indicated as monotherapy for the:...maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
    Test:
    BRACAnalysis CDx™, Myriad myChoice® CDx
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Ovarian cancer/Fallopian Tube cancer/Primary Peritoneal cancer: NCCN Recommended Options for Maintenance After First-Line Chemotherapy:...BRCA1/2 mutated...Recommended Options...olaparib.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ESMO 2018
    Title:

    Maintenance olaparib following platinum-based chemotherapy in newly diagnosed patients (pts) with advanced ovarian cancer (OC) and a BRCA1/2 mutation (BRCAm): Phase III SOLO1 trial

    Published date:
    11/01/2018
    Excerpt:
    SOLO1 is a randomized, controlled, double-blind trial. Eligible pts had newly diagnosed, FIGO stage III–IV, high-grade serous or endometrioid ovarian, primary peritoneal and/or fallopian tube cancer with a BRCAm….Maintenance olaparib led to a substantial, unprecedented improvement in PFS, with an estimated difference in median PFS for olaparib versus placebo of approximately 3 years.
    DOI:
    10.1093/annonc/mdy483.002
    Trial ID:
    SOLO-1
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Olaparib in Combination With Carboplatin for Refractory or Recurrent Women s Cancers

    Excerpt:
    ...Men with BRCA1/2 mutation and metastatic breast cancer will be eligible for study....
    Trial ID:
    NCT01237067
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2023
    Title:

    Safety and survival in adult women with platinum sensitive relapsed BRCA mutant ovarian cancer: A study of patients in Olaparib Turkey Early Access Program—LynTurk study.

    Published date:
    05/25/2023
    Excerpt:
    Patients with BRCA mutated relapsed ovarian cancer who are in complete or partial response following platinum based chemotherapy were eligible for Olaparib maintenance….All patients have high grade serous adenocarcinoma of ovary or primary peritoneal carcinoma....Median progression free survival from the end of last chemotherapy was 19.3 months. One-year PFS rate was 88.4% and 2-y PFS rate was 53.8%. One-year OS rate from the end of chemotherapy was 92.3% and 2-year was 61.5%....The real world data from Turkey managed access program has showed that Olaparib has a safety profile in paralel with clinical trials (SOLO).
    DOI:
    10.1200/JCO.2023.41.16_suppl.e17509