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    TEST:
    cobas® EZH2 Mutation Test

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

    [EZH2 mutation-Follicular Lymphoma-tazemetostat]

    Source:
    Eisai Press Release
    Test:

    cobas® EZH2 Mutation Test

    Title:
    ANTICANCER AGENT “TAZVERIK® TABLETS 200mg” (TAZEMETOSTAT HYDROBROMIDE) APPROVED IN JAPAN FOR EZH2 GENE MUTATION-POSITIVE FOLLICULAR LYMPHOMA
    Published date:
    06/23/2021
    Excerpt:
    Eisai Co., Ltd:...announced today that it has obtained manufacturing and marketing approval for the EZH2 inhibitor “Tazverik® Tablets 200 mg” (tazemetostat hydrobromide) in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive follicular lymphoma...
    Evidence Level:
    Sensitive: A1 - Approval

    [EZH2 mutation-Follicular Lymphoma-tazemetostat]

    Source:
    FDA
    Test:

    cobas® EZH2 Mutation Test

    Published date:
    07/07/2020
    Excerpt:
    ...the FDA approved the EZH2 inhibitor for use in patients with relapsed/refractory follicular lymphoma who also have tumors that harbor EZH2 mutations, as detected by an FDA-approved test, and who have received a minimum of 2 prior systemic therapies or have no other satisfactory treatment options available to them.
    Evidence Level:
    Sensitive: C3 – Early Trials

    [EZH2 mutation-Follicular Lymphoma-tazemetostat]

    Source:
    Wiley Online Library
    Test:

    cobas® EZH2 Mutation Test

    Title:
    INTERIM REPORT FROM A PHASE 2 MULTICENTER STUDY OF TAZEMETOSTAT, AN EZH2 INHIBITOR, IN PATIENTS WITH RELAPSED OR REFRACTORY B-CELL NON-HODGKIN LYMPHOMAS
    Published date:
    07/07/2020
    Excerpt:
    The ORR (CR + PR) was 40% in pts with DLBCL with EZH2 mutations (N  = 10), 18% in pts with DLBCL with wt EZH2 (N  = 85), 63% in FL pts with EZH2 mutations (N  = 8), and 28% in FL pts with wt EZH2 (N  = 46)….This phase 2 interim assessment shows preliminary clinical activity of tazemetostat with a favourable safety profile in pts with R/R DLBCL and FL, with preferential benefit in pts whose tumours bear activating EZH2 mutations.
    DOI:
    https://doi.org/10.1002/hon.2437_3
    Evidence Level:
    Sensitive: C3 – Early Trials

    [EZH2 mutation-Diffuse Large B Cell Lymphoma-tazemetostat]

    Source:
    ASH 2018
    Test:

    cobas® EZH2 Mutation Test

    Title:
    Interim Results from an Ongoing Phase 2 Multicenter Study of Tazemetostat, an EZH2 Inhibitor, in Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
    Published date:
    11/01/2018
    Excerpt:
    ...study is evaluating tazemetostat in pts with either mt or wt EZH2 R/R DLBCL...ORRs of 17% in both mt and wt arms and 9% in the prednisolone arm. Notably, DOR was substantially greater in the mt arm.
    DOI:
    10.1182/blood-2018-99-113411
    Trial ID:
    E7438-G000-101