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FDA Approvals, News & UpdatesNewsworthy

Kisqali a New First-Line Treatment for Patients with Advanced Breast Cancer

In March 2017, the FDA approved Kisqali (ribociclib), in combination with an aromatase inhibitor, for the first-line treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.
April 2017 Vol 3 No 2

In March 2017, the FDA approved Kisqali (ribociclib), in combination with an aromatase inhibitor, for the first-line treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.

The study that led to the FDA approval of Kisqali showed that using this oral drug, in combination with an aromatase inhibitor, Femara (letrozole), reduced death risk by 44% and prolonged the time without disease progression versus letrozole alone. More than half (53%) of patients responded to Kisqali plus letrozole versus 37% of patients who responded to letrozole alone.

“These results affirm that combination therapy with a CDK4/6 inhibitor like ribociclib and an aromatase inhibitor should be a new standard of care for initial treatment of HR+ advanced breast cancer,” said Gabriel N. Hortobagyi, MD, Professor of Medicine, Department of Breast Medical Oncology, M.D. Anderson Cancer Center, Houston, and principal investigator of MONALEESA-2, the clinical trial that led to the FDA approval.

The most common side effects with Kisqali plus letrozole included neutropenia, leukopenia, headache, back pain, nausea, diarrhea, vomiting, constipation, alopecia, and fatigue. For more information visit www.us.kisqali.com.

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Last modified: October 5, 2017

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