Prescribing information (external link)
Early breast cancer (eBC) patient eligibility
Indications:1
KISQALI® (ribociclib), 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 eligibility criteria)
In pre/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 information on the safety profile of KISQALI in eBC, click here.
Please refer to the Summary of Product Characteristics (SmPC) for the full safety profile.
You can offer KISQALI + AI to a broad range of your eligible HR+/HER2− eBC patients*1,2
Use the form below to assess whether your patient with HR+/HER2– eBC could be eligible for treatment with KISQALI + AI
Please note, this form is intended to provide reference information and does not replace clinical judgment. Healthcare professionals must exercise their own clinical expertise and consult relevant guidelines, as needed.
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 Ki67 ≥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; NSAI, non-steroidal aromatase inhibitor; 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.
Slamon DJ, et al. Ther Adv Med Oncol 2023;15:17588359231178125.
Slamon D, et a. N Engl J Med 2024;390(12):1080–1091 and study protocol.
UK | January 2026 | FA-11576736
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 [email protected] or call 01276 698370.
