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    TEST:
    VENTANA FOLR1 RxDx Assay

    Company:
    Roche
    Type:
    FDA Approved
    Related tests:
    Evidence Level:
    Sensitive: A1 - Approval

    [FOLR1 positive-Ovarian Cancer-bevacizumab + mirvetuximab soravtansine-gynx]

    Source:
    PRNewswire
    Test:

    VENTANA FOLR1 RxDx Assay

    Title:
    U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients
    Published date:
    03/22/2024
    Excerpt:
    ...the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies.
    Evidence Level:
    Sensitive: A1 - Approval

    [FOLR1 positive-Peritoneal Cancer-mirvetuximab soravtansine-gynx]

    Source:
    PRNewswire
    Test:

    VENTANA FOLR1 RxDx Assay

    Title:
    U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients
    Published date:
    03/22/2024
    Excerpt:
    ...the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies.
    Evidence Level:
    Sensitive: A1 - Approval

    [FOLR1 positive-Fallopian Tube Cancer-mirvetuximab soravtansine-gynx]

    Source:
    PRNewswire
    Test:

    VENTANA FOLR1 RxDx Assay

    Title:
    U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients
    Published date:
    03/22/2024
    Excerpt:
    ...the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies.
    Evidence Level:
    Sensitive: A1 - Approval

    [FOLR1 positive-Ovarian Cancer-mirvetuximab soravtansine-gynx]

    Source:
    FDA
    Test:

    VENTANA FOLR1 RxDx Assay

    Published date:
    11/14/2022
    Excerpt:
    ELAHERE is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
    Evidence Level:
    Sensitive: B - Late Trials

    [FOLR1 overexpression-Ovarian Cancer-mirvetuximab soravtansine-gynx]

    Source:
    ESGO 2023
    Test:

    VENTANA FOLR1 RxDx Assay

    Title:
    1015 - Mirvetuximab Soravtansine Demonstrates Longer Overall Survival And Progression-Free Survival By Prior Lines Of Therapy Vs Chemotherapy In Platinum-Resistant Ovarian Cancer And High Folate Receptor Alpha Expression In The MIRASOL Trial
    Published date:
    09/18/2023
    Excerpt:
    453 PROC pts with high FRα expression (Roche FOLR1 Assay), 1-3 PLOT were randomized 1:1 to MIRV or IC: paclitaxel, pegylated liposomal doxorubicin, or topotecan….MIRV demonstrated a longer OS and PFS vs IC, regardless of the number of PLOT.
    Trial ID:
    MIRASOL
    Evidence Level:
    Sensitive: B - Late Trials

    [FOLR1 overexpression-Ovarian Cancer-mirvetuximab soravtansine-gynx]

    Source:
    ASCO 2023
    Test:

    VENTANA FOLR1 RxDx Assay

    Title:
    Phase III MIRASOL (GOG 3045/ENGOT-ov55) study: Initial report of mirvetuximab soravtansine vs. investigator's choice of chemotherapy in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression.
    Published date:
    05/25/2023
    Excerpt:
    453 PROC pts with high FRα expression (Roche FOLR1 Assay) with 1-3 priors were randomized 1:1 to MIRV 6 mg/kg...MIRV is the first treatment to demonstrate a PFS and OS benefit in PROC compared to IC.
    DOI:
    10.1200/JCO.2023.41.17_suppl.LBA5507
    Trial ID:
    MIRASOL
    Evidence Level:
    Sensitive: B - Late Trials

    [FOLR1 positive-Ovarian Cancer-mirvetuximab soravtansine-gynx]

    Source:
    Immunogen Press Release
    Test:

    VENTANA FOLR1 RxDx Assay

    Title:
    ELAHERE® Demonstrates Overall Survival Benefit in the Phase 3 MIRASOL Trial in Patients with FRα-Positive Platinum-Resistant Ovarian Cancer
    Published date:
    05/03/2023
    Excerpt:
    ImmunoGen Inc...announced positive top-line data from the Phase 3 confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of ELAHERE® (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer who have received one to three prior lines of therapy...ELAHERE demonstrated a statistically significant and clinically meaningful improvement in PFS by investigator assessment compared to IC chemotherapy, with a hazard ratio of 0.65 (p<0.0001)...
    Trial ID:
    MIRASOL