Efficacy in pre/perimenopausal 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 (ET). In pre- or perimenopausal women, the ET should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.1

KISQALI is not recommended to be used in combination with tamoxifen.1

In MONALEESA-7, ET refers to LHRH plus either NSAI or tamoxifen.4

*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 70.8-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 + ET achieved mOS of 58.7 months vs 47.7 months with placebo + ET (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; LHRH, luteinising hormone-releasing hormone; mOS, median overall survival; NSAI, non-steroidal aromatase inhibitor.

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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 online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email medinfo.uk@novartis.com or call 01276 698370.