For Healthcare Professionals Outside the US
KISQALI is indicated for the treatment of women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)—negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist.
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Patients were stratified by the presence or absence of lung or liver metastases and prior endocrine therapy (treatment-naïve in the advanced setting vs having received up to one line of endocrine therapy for advanced disease). The primary end point was locally assessed PFS using RECIST v1.1. Secondary end points included OS, ORR, clinical benefit rate, and safety and tolerability.1-3