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    TEST:
    cobas® 4800 BRAF V600 Mutation Test

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

    [BRAF V600E-Melanoma-vemurafenib + cobimetinib]

    Source:
    FDA
    Test:

    cobas® 4800 BRAF V600 Mutation Test

    Excerpt:
    COTELLIC is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
    Evidence Level:
    Sensitive: A1 - Approval

    [BRAF V600E-Melanoma-vemurafenib]

    Source:
    FDA
    Test:

    cobas® 4800 BRAF V600 Mutation Test

    Excerpt:
    ZELBORAF is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
    Evidence Level:
    Sensitive: A1 - Approval

    [BRAF V600K-Melanoma-vemurafenib + cobimetinib]

    Source:
    FDA
    Test:

    cobas® 4800 BRAF V600 Mutation Test

    Excerpt:
    COTELLIC is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
    Evidence Level:
    Sensitive: A2 - Guideline

    [BRAF V600E-Cutaneous Melanoma-vemurafenib + cobimetinib]

    Source:
    NCCN
    Test:

    FoundationOne® CDx, cobas® 4800 BRAF V600 Mutation Test

    Published date:
    02/19/2021
    Excerpt:
    Melanoma: Cutaneous...BRAF/MEK Combinations…Vemurafenib/cobimetinib…Unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test
    Evidence Level:
    Sensitive: A2 - Guideline

    [BRAF V600E-Cutaneous Melanoma-vemurafenib]

    Source:
    NCCN
    Test:

    FoundationOne® CDx, cobas® 4800 BRAF V600 Mutation Test

    Published date:
    02/19/2021
    Excerpt:
    Melanoma: Cutaneous...BRAF Targeted Therapies…Vemurafenib...Unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test
    Evidence Level:
    Sensitive: B - Late Trials

    [BRAF V600E-Melanoma-vemurafenib]

    Source:
    N Engl J Med
    Test:

    cobas® 4800 BRAF V600 Mutation Test

    Title:
    Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation
    Excerpt:
    A phase 3 randomized clinical trial comparing vemurafenib with dacarbazine in 675 patients with previously untreated, metastatic melanoma with the BRAF V600E mutation....At 6 months, overall survival was 84% (95% confidence interval [CI], 78 to 89) in the vemurafenib group and 64% (95% CI, 56 to 73) in the dacarbazine group....Response rates were 48% for vemurafenib and 5% for dacarbazine….Vemurafenib produced improved rates of overall and progression free survival in patients with previously untreated melanoma with the BRAF V600E mutation.
    Secondary therapy:
    dacarbazine
    DOI:
    10.1056/NEJMoa1103782
    Trial ID:
    BRIM 3
    Evidence Level:
    Sensitive: C4 – Case Studies

    [BRAF V600-Ocular Melanoma-vemurafenib]

    Source:
    Hindawi
    Test:

    cobas® 4800 BRAF V600 Mutation Test

    Title:
    Systemic Treatment of Metastatic Conjunctival Melanoma
    Published date:
    10/26/2017
    Excerpt:
    A mutation in exon 15 of the BRAF gene (V600) was detected by Cobas 4800….In April 2014, systemic therapy was initiated with vemurafenib (960 mg) twice a day….After one month of therapy, there was full symptomatic resolution….Recent reevaluation showing sustained complete response to vemurafenib, 34 months after starting the treatment...
    DOI:
    https://doi.org/10.1155/2017/4623964