• FDA grants fast track designation to gedatolisib for breast cancer subset

    4 monthes ago - By Healio

    The FDA granted fast track designation to gedatolisib for treatment of certain patients with breast cancer.
    The designation applies to use of the agent by individuals with hormone receptor-positive, HER2-negative metastatic breast cancer whose disease progressed on cyclin-dependent kinase 4/6 inhibitor therapy.
    The FDA's fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases.
    Gedatolisib is a pan-PI3 kinase/mTOR inhibitor.
    Results of an ongoing phase 1B trial showed gedatolisib in combination
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