FDA Approves CDK4/6 Inhibitor, Kisqali, to Treat Type of Metastatic Breast Cancer

FDA Approves CDK4/6 Inhibitor, Kisqali, to Treat Type of Metastatic Breast Cancer
The U.S. Food and Drug Administration has approved Kisqali (ribociclib), in combination with an aromatase inhibitor as first-line treatment for post-menopausal and hormone-positive, HER2-negative metastatic breast cancer patients. The approval was granted to Novartis under the FDA's breakthrough therapy designation and priority review programs. It was based on data from a Phase 3 trial assessing the safety and efficacy Kisqali plus Femara (letrozole) versus Femara alone, which met its primary endpoint of progression-free survival at interim analysis. Kisqali is a selective inhibitor of the CDK4/6 proteins, which when overactive can lead to unregulated proliferation of cancer cells.  Targeting CDK4/6 with high precision may halt the uncontrolled replication of cancer cells. The recent approval was based on data from the MONALEESA-2 Phase 3 trial (NCT01958021), a randomized and double-blind study that enrolled 668 patients with postmenopausal HR-positive, HER2-negative advanced breast cancer to study Kisqali plus Femara as first-line therapy. Participants were randomized to receive Kisqali (600 mg a day, in monthly cycles marked by three weeks of treatment with a one-week pause) in combination with Femara ( 2.5 mg/day), or a placebo plus Femara. At the interim analysis, the trial had met its primary endpoint, with patients on Kisqali showing a 44 percent reduction in the risk of disease progression. While those on Femala monotherapy had a median progression-free survival (PFS) of 14.7 months at this point, those in the Kisqali treatment group had not yet reached median PFS — more than half of these patients remained disease-free at the time of th
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