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FDA Expands Ribociclib Breast Cancer Approval Under New Pilot Programs

Jason M. Broderick @jasoncology
Published: Wednesday, Jul 18, 2018

The FDA has approved upfront ribociclib (Kisqali) for use in combination with an aromatase inhibitor (AI) for the treatment of pre/perimenopausal or postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer. The agency also approved the CDK4/6 inhibitor for use in combination with fulvestrant for the treatment of postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer, in the frontline setting or after disease progression on endocrine therapy.
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