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Quantifying Antibody-Dependent Cellular Cytotoxicity in a Tumor Spheroid Model: Application for Drug Discovery
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FDA OKs Abemaciclib for ER+, HER2- Breast Cancer

    Cancer Discovery
    |October 6, 2017
    PubMed

    Insights

    The FDA approved abemaciclib for advanced ER-positive, HER2-negative breast cancer progressing on endocrine therapy. This marks the third CDK4/6 inhibitor approval in under three years.

    Area of Science:

    • Oncology
    • Pharmacology

    Background:

    • Estrogen receptor-positive (ER-positive), human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer is a common subtype.
    • Endocrine therapy is a standard treatment, but resistance and progression are significant challenges.

    Purpose of the Study:

    • To report the U.S. Food and Drug Administration (FDA) approval of abemaciclib.
    • To highlight the significance of this approval for patients with advanced or metastatic breast cancer.

    Main Methods:

    • Review of FDA regulatory submission data.
    • Analysis of clinical trial outcomes for abemaciclib in the specified patient population.

    Main Results:

    • Abemaciclib received FDA approval for advanced or metastatic ER-positive, HER2-negative breast cancer.
    • The drug is indicated for patients whose disease has progressed on prior endocrine therapy.

    Conclusions:

    • Abemaciclib provides a new therapeutic option for a specific group of breast cancer patients.
    • The approval underscores the growing importance of CDK4/6 inhibitors in breast cancer treatment.

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