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FDA Approves Trastuzumab Biosimilar

    Cancer Discovery
    |December 24, 2017
    PubMed

    Insights

    The FDA approved trastuzumab-dkst, a second cancer biosimilar, for treating HER2-positive breast and metastatic stomach cancers. This approval offers new treatment options for patients with these specific oncological conditions.

    Area of Science:

    • Oncology
    • Pharmacology

    Background:

    • The development of biosimilars is crucial for expanding patient access to targeted cancer therapies.
    • Trastuzumab is a well-established monoclonal antibody for HER2-positive cancers.

    Purpose of the Study:

    • To announce the FDA approval of trastuzumab-dkst as a biosimilar.
    • To indicate the approved indications for trastuzumab-dkst.

    Main Methods:

    • FDA regulatory review process.
    • Assessment of analytical, clinical, and non-clinical data for biosimilarity.

    Main Results:

    • FDA approval of trastuzumab-dkst on December 1.
    • Designation as the second approved cancer biosimilar.
    • Approved for treatment of HER2-positive breast cancer.
    • Approved for treatment of metastatic stomach cancer.

    Conclusions:

    • Trastuzumab-dkst provides a new biosimilar treatment option for patients with HER2-positive breast and metastatic stomach cancers.
    • This approval signifies progress in the availability of affordable biologic cancer medications.

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