Kisqali

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Kisqali (chemical name: ribociclib, formerly called LEE011) was approved by the U.S. Food and Drug Administration (FDA) on March 13, 2017 to be used in combination with an aromatase inhibitor to treat advanced-stage or metastatic hormone-receptor-positive, HER2-negative breast cancer that hasn’t been treated with hormonal therapy yet in postmenopausal women.

On Jan. 3, 2018, Kisqali was granted breakthrough therapy designation by the FDA to be used in combination with tamoxifen or an aromatase inhibitor to treat advanced-stage or metastatic hormone-receptor-positive, HER2-negative breast cancer that hasn’t been treated with hormonal therapy yet in premenopausal women.

Breakthrough therapy designation means the FDA will expedite the approval process for the proposed used of the medicine.

Kisqali is a pill taken by mouth.

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