Efficacy in postmenopausal women with HR+/HER2– aBC
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 luteinising hormone-releasing hormone agonist.1
KISQALI is not recommended to be used in combination with tamoxifen.1
ET refers to either AI or fulvestrant.
*MONALEESA-2: At median 80-month follow-up, KISQALI + AI achieved mOS of 63.9 months vs 51.4 months with placebo + AI (HR=0.76; 95% CI: 0.63–0.93; p=0.008).2 MONALEESA-3: At median 71-month follow-up, KISQALI + fulvestrant achieved mOS of 67.6 months vs 51.8 months with placebo + fulvestrant (HR=0.67; 95% CI: 0.50–0.90).3 MONALEESA‑7: At median 54-month follow‑up, KISQALI + AI achieved mOS of 58.7 months vs 47.7 months with placebo + AI (HR=0.80; 95% CI: 0.62–1.04).4
aBC, advanced breast cancer; AI, aromatase inhibitor; CI, confidence interval; ET, endocrine therapy; HER2–, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive.
Prescribing information can be accessed by clicking the button below.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via uk.patientsafety@novartis.com or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at medinfo.uk@novartis.com.
References
1. KISQALI® (ribociclib) Summary of Product Characteristics.
2. Hortobagyi GN, et al. N Engl J Med 2022;386(10):942–950.
3. Neven P, et al. Breast Cancer Res 2023;25:103.
4. Lu Y-S, et al. Clin Cancer Res 2022;28:851–859.
