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FDA Approves First Biosimilar to Treat Cancer

    Cancer Discovery
    |October 7, 2017
    PubMed

    Insights

    The FDA approved bevacizumab-awwb, a biosimilar VEGF inhibitor, for treating five major cancers. This marks the first approval of a biosimilar cancer treatment agent.

    Area of Science:

    • Oncology
    • Pharmacology

    Background:

    • Vascular Endothelial Growth Factor (VEGF) inhibitors are crucial in cancer therapy.
    • Bevacizumab is an established anti-VEGF agent used in treating various malignancies.
    • The development of biosimilars offers potential for increased accessibility to effective cancer treatments.

    Purpose of the Study:

    • To report the FDA approval of bevacizumab-awwb, a biosimilar to bevacizumab.
    • To highlight the therapeutic indications for this new biosimilar agent.

    Main Methods:

    • The study is based on the FDA's regulatory review and approval process.
    • The approval decision was based on comprehensive data demonstrating biosimilarity and therapeutic equivalence.

    Main Results:

    • The U.S. Food and Drug Administration (FDA) approved bevacizumab-awwb.
    • Bevacizumab-awwb is indicated for the treatment of nonsquamous non-small cell lung cancer, metastatic colorectal cancer, cervical cancer, renal cell carcinoma, and glioblastoma.
    • This approval signifies the first instance of a biosimilar VEGF inhibitor being authorized for oncologic indications.

    Conclusions:

    • Bevacizumab-awwb represents a significant advancement in cancer therapy by providing a biosimilar option.
    • The availability of this biosimilar is expected to enhance treatment accessibility for patients with specific types of cancer.

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