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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Dosing-with-AI
RIBG21BLNY5065_MONALEESA-7-D

Patients were stratified by the presence of liver and/or lung metastases, prior chemotherapy for advanced disease, and endocrine combination partner. The primary end point was PFS using RECIST v1.1; secondary end points included OS, ORR, QoL, and safety. The efficacy results presented are from a prespecified subgroup analysis of 495 patients who had received KISQALI or placebo with an AI plus an LHRH agonist. A separate cohort of 179 patients was randomized to receive KISQALI 600 mg once daily (3 weeks on, 1 week off) in combination with tamoxifen 20 mg (once daily on a continuous basis) plus an LHRH agonist. KISQALI is not indicated for concomitant use with tamoxifen.1-3

See 1L premenopausal data with ET >
aBC, advanced breast cancer; ET, endocrine therapy; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; QoL, quality of life; RECIST, Response Evaluation Criteria In Solid Tumors.
References: 1. KISQALI [Summary of Product Characteristics]. Novartis Pharma AG; 2019. 2. Tripathy D, Im S-A, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2019;19(7):904-915. 3. Harbeck N, Franke F, Villanueva-Vazquez R, et al. Health-related quality of life in premenopausal women with hormone-receptor-positive, HER2- negative advanced breast cancer treated with ribociclib plus endocrine therapy: results from a phase III randomized clinical trial (MONALEESA-7). Ther Adv Med Oncol. 2020;12:1758835920943065.
Disclaimer: This is a global website for KISQALI® (ribociclib) and is intended for Healthcare Professionals outside the US. The information on the site is not country-specific and may contain information that is outside the approved indications in the country in which you are located. Please contact your local Novartis representative for the latest information specific to your country. Please contact your local representative for local prescribing information via novartis.com/contacts
IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EUSmPC)
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