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Patient eligibility for KISQALI® (ribociclib) in eBC
Indication:1
KISQALI, in combination with an aromatase inhibitor (AI), is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) at high risk of recurrence (see section 5.1 of the SmPC for selection criteria).
In pre- or perimenopausal women, or in men, the AI should be combined with a luteinising hormone-releasing hormone (LHRH) agonist
KISQALI is not recommended to be used in combination with tamoxifen.
For more information on the safety profile in eBC, click here.
Please consult your local Summary of Product Characteristics (SmPC) for the full KISQALI safety and tolerability profile.
You can offer KISQALI + AI to a broad range of your HR+/HER2− eBC patients*1,2
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Explore the efficacy outcomes of KISQALI in eBC
Learn about the safety profile of KISQALI in eBC
*KISQALI in combination with an AI is indicated for the adjuvant treatment of patients with hormone receptor HR+/HER2– eBC at high risk of recurrence. This includes patients with lymph node-positive cancer, or if no nodal involvement, either tumour size >5 cm, or tumour size 2–5 cm with either grade 2 and high genomic risk or Ki-67 ≥20%, or grade 3. AI should be combined with an LHRH agonist.1
†Genomic risk is defined as an Oncotype DX Breast Recurrence Score of ≥26, or Prosigna/PAM50, MammaPrint, or EndoPredict EPclin high-risk scores.1,2
AI, aromatase inhibitor; eBC, early breast cancer; ET, endocrine therapy; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; LHRH, luteinising hormone-releasing hormone; N0, no nodal involvement; N1, 1–3 axillary lymph nodes; N2, 4–9 axillary lymph nodes; N3, ≥10 axillary lymph nodes or collarbone lymph nodes; SmPC, summary of product characteristics; T, tumour; T2, tumour is more than 2 cm but less than 5 cm; T3, tumour is more than 5 cm; T4, tumour of any size growing into the chest wall or skin, includes inflammatory breast cancer.
References
KISQALI® (ribociclib) Summary of Product Characteristics. Available at: www.medicines.ie.
- Slamon DJ, et al. Ther Adv Med Oncol 2023;15:1–16.
IE11637235 | June 2026
