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KISQALI® (ribociclib) in eligible patients with HR+/HER2– 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.
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Now you can offer KISQALI + AI to a broad range of your HR+/HER2– eBC patients, including those with N1 and high-risk N0 disease*1,2
KISQALI + Al is indicated for the adjuvant treatment of patients with HR+/HER2− eBC at high risk of recurrence1
Eligible patients include those 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 31
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KISQALI can be added as adjuvant treatment for up to 12 months after the start of ET in eBC patients3
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KISQALI + NSAI prevented 1 in 4 invasive disease, recurrence or death events over 3 years vs placebo + NSAI (HR=0.75; 95% CI:0.62–0.91, p=0.003; ARR=3.1%)1,3
At the pre-specified 5 year follow-up analysis in HR+/HER2– patients, KISQALI + NSAI was observed to reduce the risk of invasive disease, recurrence or death by 28.4% vs NSAI (HR=0.716; 95% CI: 0.618–0.829; p<0.001 [nominal p-value]; ARR=4.5%)4
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KISQALI + NSAI demonstrated a manageable and well characterised safety profile with no new safety signals identified at 5 years1–4
The most common adverse drug reactions (reported at a frequency ≥20%) in the dataset for which the frequency for KISQALI + AI exceeds the frequency for AI alone were neutropenia, infections,nausea, headache, fatigue, leukopenia and abnormal liver function tests1
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*KISQALI was evaluated in a randomised, open-label, multicentre Phase III clinical study in the treatment of pre-/postmenopausal women, and of men, with HR+/HER2– eBC with anatomic stage II or III irrespective of nodal status at high risk of recurrence in combination with an NSAI (letrozole or anastrozole) versus NSAI alone that was:1
Anatomic stage group IIB-III, or
Anatomic stage group IIA that is either:
Node positive or
Node negative, with:
Histologic grade 3, or
Histologic grade 2, with any of the following criteria:
Ki-67 ≥20%
High risk by gene signature testing
AI, aromatase inhibitor; ARR, absolute risk reduction; CI, confidence interval; eBC, early breast cancer; ET, endocrine therapy; HER2–, human epidermal growth receptor 2 negative; HR, hazard ratio; HR+, hormone receptor-positive; LHRH, luteinising hormone-releasing hormone; NSAI, non-steroidal anti-inflammatory; SmPC, summary of product characteristics.
References
KISQALI® (ribociclib) Summary of Product Characteristics. Available at www.medicines.ie.
Hortobagyi GN, et al. Ann Oncol 2025;36(2):149–157.
Slamon DJ, et al. New Engl J Med 2024;390(12):1080–1091.
Crown JP, et al. ESMO Open 2025;10(11):105858.
IE11641403 | April 2026
