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    Home > Active Ingredient News > Antitumor Therapy > The European Commission on Medicines for Human Use (CHMP) has positive opinions on sacituzumab govitecan monotherapy for triple-negative breast cancer (TNBC)

    The European Commission on Medicines for Human Use (CHMP) has positive opinions on sacituzumab govitecan monotherapy for triple-negative breast cancer (TNBC)

    • Last Update: 2021-10-20
    • Source: Internet
    • Author: User
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    Triple negative breast cancer (TNBC) is the most aggressive type of breast cancer, accounting for approximately 15% of all breast cancers
    .


    It is more commonly diagnosed in young and premenopausal women, and more common in black and Hispanic women


    Breast cancer diagnosis Sacituzumab govitecan is a first-class Trop-2 targeted antibody drug conjugate


    This positive opinion is supported by the results of the Phase III ASCENT study, in which sacituzumab govitecan reduced the risk of disease progression or death by 57%, and increased the median progression-free survival (PFS) from 1.
    7 months to 4.
    8 months (Figure 1 )
    .


    Sacituzumab govitecan also improved the median overall survival to 11.


    This positive opinion is supported by the results of the Phase III ASCENT study, in which sacituzumab govitecan reduced the risk of disease progression or death by 57% and increased the median progression-free survival (PFS) from 1.


    Figure 1.
    ASCENT study

    Sacituzumab govitecan (trade name Trodelvy®) has been approved for the treatment of metastatic TNBC in Australia, Canada, the United Kingdom, Switzerland and the United States
    .

    Merdad Parsey, MD, Chief Medical Officer of Gilead Sciences, said: “For patients with metastatic TNBC, effective treatment options are extremely limited
    .


    We are encouraged by the positive opinions of CHMP because we are now close to bringing this much-needed treatment option to Patients across Europe are one step closer


     

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