FDA expands use of Novartis’ Kisqali

September 2018—Novartis announced FDA approval for Kisqali (ribociclib) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer. Kisqali is a CDK4/6 inhibitor indicated for use with an aromatase inhibitor for the treatment of pre-, peri-, or postmenopausal women and is also indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women. The FDA reviewed this supplemental new drug application under its Real-Time Oncology Review and Assessment Aid pilot programs and approved the application in less than one month after submission.

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