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Prescribing information

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KISQALI® (ribociclib) in eligible patients with HR+/HER2– aBC1

Indication:1

  • 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 (aBC) in combination with an aromatase inhibitor (AI) 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 

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

For more information on the safety profile in aBC, click here.

Please consult your local Summary of Product Characteristics (SmPC) for the full KISQALI safety and tolerability profile.

Circle with the letters 'OS'.

In HR+/HER2– aBC, KISQALI + ET* is the only CDK4/6i with significant 1L OS benefit across three Phase III trials vs placebo + ET2–4

  • MONALEESA-2:  At a median follow-up of 6.6 years, mOS was 63.9 months with KISQALI + AI (n=334) vs 51.4 months with placebo + AI (n=334) (HR for death=0.76; 95% CI: 0.63–0.93; two-sided p=0.008)†2

  • MONALEESA-3: At median follow-up of 70.8 months, mOS was 67.6 vs 51.8 months with 1L KISQALI vs placebo (HR=0.67; 95% CI: 0.50–0.90)†5

  • MONALEESA-7: The estimated OS at 42-month follow-up was 70.2% (95% CI: 63.5–76.0) in the KISQALI + ET group (n=335) and 46.0% (95% CI: 32.0–58.9) in the placebo + ET group (n= 337) (HR for death=0.71; 95% CI: 0.54–0.95; p=0.00973 by log-rank test)†6

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KISQALI + ET* preserved QoL (EORTC or TTD) across all three Phase III trials vs placebo + ET‡7–10

  • Patient-reported outcomes for health-related QoL were secondary endpoints7–10

  • MONALEESA-2: KISQALI + AI maintained QoL (mTTD ≥10%) for 27.7 months vs 27.6 months with placebo + AI (HR=0.94 95% CI: 0.72–1.24)†8

  • MONALEESA-3: TTD ≥10% in EORTC QLQ-C30 functioning scores trended in favour of KISQALI. Mean TTD ≥10% with KISQALI vs placebo was 38.7 months (137 events) vs 34.9 months (69 events; HR=0.82; 95% CI: 0.61–1.10)†9

  • MONALEESA-7: KISQALI + ET + LHRH maintained QoL (mTTD ≥10%) for 35.8 months vs 23.3 months with placebo + ET+ LHRH (HR=0.67; 95% CI: 0.52–0.86)†10

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 KISQALI safety profile1

  • KISQALI + ET* has a generally manageable and well-characterised safety profile1,11,12

  • Please consult KISQALI SmPC for full information on adverse events (AEs), special warnings and precautions for use and contraindications in aBC1

  • Most common AEs associated with KISQALI in aBC were neutropenia, infections, nausea, fatigue, diarrhoea, leukopenia, vomiting, headache, constipation, alopecia, cough, rash, back pain, anaemia and abnormal liver function tests1

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*ET is defined as AI or fulvestrant, and LHRH.2–4
†MONALEESA-2 primary endpoint: The primary endpoint of PFS was significantly longer with KISQALI + AI vs placebo + AI  (25.3 months vs 16.0 months, respectively; HR for disease progression or death=0.57; 95% CI:0.46–0.70; p<0.001).13 MONALEESA-3 primary endpoint: The primary endpoint of PFS was significantly improved with KISQALI + fulvestrant vs placebo + fulvestrant: 20.5 months vs 12.8 months, respectively; HR=0.593; 95% CI: 0.480–0.732; p<0.001.14 MONALEESA-7 primary endpoint: The primary endpoint of PFS per investigator’s assessment was 23.8 months (95% CI: 19.2–not reached) in the KISQALI group compared with 13.0 months (11.0–16.4) in the placebo group (HR=0.55, 95% CI: 0.44–0.69; p<0.0001).15
‡QoL was assessed using the EORTC QLQ-C30 questionnaire, a validated tool used worldwide to assess QoL in patients with cancer. Time to definitive deterioration 10% (TTD; defined as ≥10% worsening of the scale score relative to baseline, with no later improvement above this threshold observed during the treatment period, or death due to any cause) in the global health status/QoL score was investigated.7–10

1L, first-line; aBC, advanced breast cancer; AE, adverse event; AI, aromatase inhibitor; ARR, absolute risk reduction; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; eBC, early breast cancer; EORTC-QLQ C30, European Organisation for Research and Treatment of Cancer core quality of life questionnaire; ET, endocrine therapy; HER2–, human epidermal growth receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; LHRH, luteinising hormone-releasing hormone; mOS, median overall survival; mTTD, median time to deterioration; OS, overall survival; PFS, progression-free survival; QoL, quality of life; SmPC, summary of product characteristics; TTD, time to deterioration.

References

  1. KISQALI® (ribociclib) Summary of Product Characteristics. Available at www.medicines.ie.

  2. Hortobagyi GN, et al. N Engl J Med 2022;386:942950.

  3. Neven P, et al. Breast Cancer Res 2023;25:103.

  4. Lu YS, et al. Clin Cancer Res 2022;28(5):851859.

  5. Slamon DJ, et al. N Engl J Med 2020;382(6):514524.

  6. Im SA, et al. N Engl J Med 2019;381(4):307316.

  7. Verma S, et al. Br Cancer Res Treat 2018;170:535545.

  8. Beck JT, et al. Abstract P6-18-14. Cancer Res 2019;79(Suppl 4). 

  9. Fasching PA, et al. Breast 2020;54:148154.

  10. Harbeck N, et al. Ther adv Med Oncol 2020;12:1758835920943065.

  11. Borstnar S, et al. Radiol Oncol 2022;65(2):238247.

  12. Jackisch C, et al. Poster P4-01-01. San Antonio Breast Cancer Symposium. 6–10 December 2022, San Antonio, TX, US.

  13. Hortobagyi GN. et al. Ann Oncol 2018;29:1541–1547.

  14. Slamon DJ, et al. J Clin Oncol 2018;36(24):24652472.

  15. Tripathy D, et al. Lancet Oncol 2018;19(7):904915.

IE11641188 | May 2026

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported to HPRA Pharmacovigilance at www.hpra.ie. Adverse events can also be reported to Novartis preferably at www.novartis.com/report, by emailing [email protected] or by calling (01) 2080 612.