^
    Back
    Association details:
    Biomarker:No biomarker
    Cancer:Tenosynovial Giant Cell Tumor
    Drug:Turalio (pexidartinib) (c-KIT inhibitor, FLT3 inhibitor, AKT inhibitor, CSF-1R inhibitor, FMS kinase inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    08/02/2020
    Excerpt:
    TURALIO is a kinase inhibitor indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Title:

    FDA approves pexidartinib for tenosynovial giant cell tumor

    Published date:
    08/02/2019
    Excerpt:
    ...the Food and Drug Administration approved pexidartinib (TURALIO™, Daiichi Sankyo) capsules for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. Pexidartinib is the first systemic therapy approved for patients with TGCT.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Lancet
    Title:

    Pexidartinib versus placebo for advanced tenosynovial giant cell tumour (ENLIVEN): a randomised phase 3 trial

    Published date:
    08/10/2019
    Excerpt:
    Pexidartinib is the first systemic therapy to show a robust tumour response in TGCT.
    DOI:
    10.1016/S0140-6736(19)30764-0
    Trial ID:
    ENLIVEN