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Prescribing information

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KISQALI® (ribociclib) efficacy in aBC

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.

Is it time to make KISQALI your 1L CDK4/6i of choice for eligible HR+/HER2– aBC patients?1

Droplet shape with the text '#1 treatment goal'.

Increasing overall survival (OS) is a 1L key treatment goal for you and your patients with HR+/HER2– aBC, as reported in a physician and patient survey*2

In HR+/HER2– aBC, KISQALI + ET is the only CDK4/6i with significant 1L OS benefit across 3 Phase III trials3–5

KISQALI is not recommended to be used in combination with tamoxifen.1

  • MONALEESA-2: At 80-months follow-up, a significant OS benefit was observed, with a mOS of 63.9 months (95% CI: 52.4–71.0) with KISQALI + AI (n=334) and 51.4 months (95% CI: 47.2–59.7) with placebo + AI (n=334) (HR for death=0.76; 95% CI: 0.63–0.93; two-sided p=0.008)3

  • MONALEESA-3: KISQALI + fulvestrant (n=484) showed a significant OS benefit over placebo + fulvestrant (n=242). The estimated OS at 42-month follow-up was 57.8% (95% CI: 52.0–63.2) in the KISQALI group and 45.9% (95% CI: 36.9–54.5) in the placebo group (HR=0.72; 95% CI: 0.57–0.92; p=0.00455)6

  • 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)7

Results are from individual studies. They are presented together for illustrative purposes only and should not be directly compared. Due to the exploratory nature of some of the analyses, the statistics are descriptive and need to be interpreted with caution.

MONALEESA-2

Primary endpoint, progression-free survival (PFS): In the primary and updated analyses, mPFS was significantly longer with KISQALI + AI (n=334) than with placebo + AI (n=334) (updated analysis: 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).3,8

Droplet shape with the text '12.5 months'.

1L KISQALI + AI increased mOS by >1 year (12.5 months) vs placebo + AI in postmenopausal patients3

  • Median follow-up of 80 months3

Secondary endpoint:

At median follow-up of 80 months, mOS was 63.9 months (95% CI: 52.4–71.0) for KISQALI + AI and 51.4 months (95% CI: 47.2–59.7) for placebo + AI (HR for death=0.76; 95% CI: 0.63–0.93, two-sided p=0.008)3

MONALEESA-3

Primary endpoint, PFS: KISQALI + fulvestrant (n=484) showed a significant benefit in PFS versus placebo + fulvestrant (n=242) with an mPFS of 20.5 months versus 12.8 months (HR=0.59; 95% CI: 0.48–0.73, p<0.001).9

Droplet shape with the text '1L'.

In an exploratory analysis, 1L KISQALI + fulvestrant was observed to demonstrate an increased OS rate vs fulvestrant + placebo in postmenopausal patients4

  • Extended median follow-up of 71 months4
Exploratory endpoint:

At a median follow-up of 71 months, mOS was 67.6 months with 1L KISQALI + fulvestrant vs 51.8 months with placebo + fulvestrant (HR=0.67; 95% CI: 0.50–0.90)4

MONALEESA-7

Primary endpoint, PFS: KISQALI + ET (n=335) (non-steroidal aromatase inhibitor [NSAI] or tamoxifen plus goserelin) was associated with significant improvement in PFS versus placebo + ET (n=337) (NSAI or tamoxifen plus goserelin), with a median of 23.8 months versus 13.0 months, respectively (HR=0.55; 95% CI: 0.44–0.69; p<0.001).5,10

Calendar icon with the text '11 months'.

In an exploratory analysis, 1L KISQALI + ET was observed to increase mOS by 11 months vs placebo + ET in pre/perimenopausal patients5

  • Exploratory analysis for the NSAI subgroup with an extended median follow-up of 54 months5

  • ET is defined as AI + LHRH

Exploratory endpoint:

At a median follow-up of 54 months, mOS was 58.7 months with KISQALI + ET vs 47.7 months with placebo + ET (HR=0.80; 95% 
CI: 0.62–1.04).5

KISQALI is not recommended to be used in combination with tamoxifen.1

Find out more about the safety profile of KISQALI in aBC

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See below for MONALEESA-2, MONALEESA-3 and MONALEESA-7 study designs.

Summary of the safety profile
The most common adverse reactions (reported at a frequency ≥20%) in the pooled dataset for which the frequency for KISQALI + any combination exceeds the frequency for placebo + any combination were neutropenia, infections, nausea, fatigue, diarrhoea, leukopenia, vomiting, headache, constipation, alopecia, cough, rash, back pain, anaemia and abnormal liver function tests.1

Study designs
MONALEESA-2: Phase III trial of KISQALI + AI (n=334) vs placebo + AI (n=334) in postmenopausal patients with HR+/HER2– aBC who had not received previous systemic therapy for advanced disease. The primary endpoint was locally assessed PFS, OS was a key secondary endopoint. In the primary and updated analyses, mPFS was significantly longer with KISQALI + AI than with placebo + AI (updated analysis: 25.3 months vs 16.0 months; HR for disease progression or death=0.57; 95% CI: 0.46–0.70, p<0.001).3,8

MONALEESA-3: Phase III trial of KISQALI + fulvestrant (n=484) vs placebo + fulvestrant (n=242) in postmenopausal patients with HR+/HER2– aBC who were treatment naïve or had received up to 1 line of prior ET in the advanced setting. The primary endpoint was locally assessed PFS. KISQALI + fulvestrant showed a significant benefit in PFS versus placebo + fulvestrant with an mPFS of 20.5 versus 12.8 months (HR=0.59; 95% CI: 0.48–0.73, p<0.001). OS was a secondary endpoint.9

MONALEESA-7: Phase III trial of KISQALI + ET (NSAI or tamoxifen) (n=335) vs placebo + ET (NSAI or tamoxifen) (n=337) in pre- and perimenopausal patients with HR+/HER2– aBC. The primary endpoint was investigator-assessed PFS. KISQALI was associated with a significant improvement in PFS, with a mPFS of 23.8 vs 13.0 months with placebo (HR=0.55; 95% CI: 0.44–0.69, p<0.001). The key secondary endpoint was OS.5,10

*Quantitative and qualitative primary research with more than 500 respondents (including 392 physicians managing metastatic breast cancer patients and patients themselves). Top reported goals included OS and maintaining day to day activities.2

1L, first-line; aBC, advanced or metastatic breast cancer; AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; CI, confidence interval; ET, endocrine therapy; HER2−, human epidermal growth factor receptor-2 negative; HR, hazard ratio; HR+, hormone receptor-positive; LHRH, luteinising hormone-releasing hormone; mOS, median overall survival; mPFS, median progression-free survival; NSAI, non-steroidal aromatase inhibitor; OS, overall survival; PFS, progression-free survival; SmPC, summary of product characteristics.

References

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

  2. Pfizer Oncology. Meaningful Goals in the Management of mBC. 2017. Available at: https://www.breastcancervision.com/sites/default/files/section-pdf/mbc_goals-whitepaper_final_with_date.pdf [Accessed May 2026].

  3. Hortobagyi GN, et al. N Engl J Med 2022;386(10):942–950.

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

  5. Lu Y-S, et al. Clin Cancer Res  2022;28:851–859.

  6. Slamon DJ, et al. N Engl J Med 2020;382:514–524.

  7. Im S-A, et al. N Engl J Med 2019;381(4):307–316.

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

  9. Slamon DJ, et al. J Clin Oncol 2018;36(24):2465–2472.

  10. Tripathy D, et al. Lancet Oncol 2018;19(7):904–915.

IE11636718 | 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.