For Healthcare Professionals Outside the US

KISQALI in combination with an aromatase inhibitor is indicated for the treatment of postmenopausal women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative locally advanced or metastatic breast cancer as initial endocrine-based therapy.

Rapid and powerful efficacy
  • KISQALI is approved based on a first-line, phase III trial that met its primary end point early due to superior efficacy vs letrozole1
  • At a subsequent analysis with an additional 11 months of follow-up, KISQALI + letrozole demonstrated a median PFS of 25.3 months vs 16.0 months with letrozole alone1
  • At a subsequent analysis with an additional 11 months of follow-up, 43.2% reduction in risk of disease progression or death was seen with KISQALI + letrozole1
  • At 8 weeks, 3 out of 4 (76%) patients with measurable disease receiving KISQALI + letrozole saw a reduction in tumor size vs 67% receiving letrozole alone2,3

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Convenience for an optimized treatment experience
  • Once-daily oral dose of 600 mg (3 x 200-mg tablets) that can be taken with or without food1
  • The only CDK4/6 inhibitor that offers adjustable dosing without the need for a new prescription mid-cycle1,4
  • EMA approved in combination with any aromatase inhibitor1

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Well-characterized safety profile
  • Predictable: AEs typically appeared early and resolved with appropriate management1
  • Manageable and reversible AEs; 7.5% of patients permanently discontinued KISQALI + letrozole due to AEs1

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AE, adverse event; CDK, cyclin-dependent kinase; EMA, European Medicines Agency.

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References: 1. KISQALI [Summary of Product Characteristics]. Novartis Pharma AG; 2017. 2. Burris HA, Chan A, Campone M, et al. First-line ribociclib + letrozole in patients with HR+, HER2– advanced breast cancer presenting with visceral metastases or bone-only disease: a subgroup analysis of the MONALEESA-2 trial. Poster presented at: San Antonio Breast Cancer Symposium; December 6-10, 2016; San Antonio, TX. Poster P4-22-16. 3. Data on file. Novartis Pharma AG. 4. Ibrance [Summary of Product Characteristics]. Sandwich, United Kingdom: Pfizer Limited; 2016.