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    1. Documents
    2. doc:hc:braftovi

    Braftovi (encorafenib) [product monograph]. HC.

    Regulatory approval published by the Health Canada.

    Citation

    Pfizer Canada ULC. Braftovi (encorafenib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00081199.PDF. Revised July 2025. Accessed April 2026.

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    Regulatory approvals

    Approved indications from this document for cancer drugs containing at least one biomarker.

    Indication Statements
    BRAFTOVI (encorafenib) is indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.
    BRAFTOVI (encorafenib) is indicated, in combination with cetuximab, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a validated test, after prior therapy.
    BRAFTOVI (encorafenib) is indicated, in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a validated test.

    Therapeutic response

    Precision oncology relationships for therapeutic response derived from this document.

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