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    Association details:
    Biomarker:No biomarker
    Cancer:Bladder Cancer
    Drug:Imfinzi (durvalumab) (PD-L1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Title:

    FDA approves durvalumab for muscle invasive bladder cancer

    Published date:
    03/28/2025
    Excerpt:
    The Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC)
    Trial ID:
    NIAGARA
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    AstraZeneca Press Release
    Title:

    Imfinzi granted FDA Priority Review for less-frequent, fixed-dose use

    Published date:
    08/18/2020
    Excerpt:
    AstraZeneca's Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications of non-small cell lung cancer (NSCLC) and bladder cancer.