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Author Topic: FDA Approves Kisqali for Premenopausal Women With Advanced Breast Cancer  (Read 1989 times)

Offline Cancer Health Editors

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The Food and Drug Administration (FDA) last week approved Kisqali (ribociclib) in combination with an aromatase inhibitor for first-line treatment of premenopausal and perimenopausal women with HR-positive/HER2-negative advanced breast cancer. It was also approved with Faslodex (fulvestrant) for postmenopausal women, either as initial treatment or after disease progression on hormone therapy.

This was the first drug to be approved using the FDA’s new Real-Time Oncology Review pilot program and Assessment Aid, with approval granted less than one month after submission of a supplemental New Drug Application.



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