All Filters
Therapeutic Area
Therapeutic Area
Format
What are you looking for?
All Filters
Therapeutic Area
Therapeutic Area
Format
top

Advanced breast cancer guideline recommendations

Indication:1

 

  • KISQALI® (ribociclib) 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 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/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.

To learn more about the safety profile of KISQALI, visit our portal page here.

For full safety profile information, please refer to the KISQALI Summary of Product Characteristics.

Advanced breast cancer (aBC) is associated with poor prognosis:2,3

 

  • A median overall survival (OS) of 3 years

 

  • 5-year survival rate of 25%

HR+/HER2– aBC is the most common subtype of metastatic breast cancer (mBC).3

Treatment is aimed at improving OS, in addition to maintaining or improving quality of life.3 Although the disease remains incurable, the availability of systemic therapies such as ET has led to improvements in the management of this hormone-sensitive disease.4

Cyclin-dependent kinases 4 and 6 (CDK4/6) play a key role in cell cycle progression and have become an effective target in the treatment of aBC.5

For more information, please visit the page on the mechanism of action of CDK4/6 inhibitors

Learn more

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

ESMO living guideline: mBC6,7

Use the arrows below to navigate through the different ESMO living guidelines for HR+/HER2– mBC.

This information is derived from the ESMO guidelines and includes off-label combinations that are not endorsed by Novartis. Please refer to individual SmPCs before prescribing.

Orange: algorithm title; light teal: systemic anticancer therapy or their combination; white: other aspects of management and non-treatment aspects.

KISQALI received an ESMO-MCBS score of 4/5 when used in combination with AI or fulvestrant9
Discover more

The ESMO-MCBS is a standardised tool that quantifies the likely magnitude of clinical benefit. The scale considers OS, progression-free survival, disease-free survival, hazard ratio, response rate, quality of life, prognosis of the condition and toxicity of patients in the non-curative setting, ranging from grades 1 to 5, with 4 and 5 denoting substantial clinical benefit.10

For further information, please refer to the ESMO-MCBS scorecard methodology.10

aBC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6, cyclin-dependent kinase 4/6; ChT, chemotherapy; EMA, European Medicines Agency; ESMO, European Society for Medical Oncology; ET, endocrine therapy; FDA, US Food and Drug Administration; HER2–, human epidermal growth receptor 2-negative; HR+, hormone receptor-positive; LHRH, luteinising hormone-releasing hormone; mBC, metastatic breast cancer; MCBS, magnitude of clinical benefit scale; OFS, ovarian function suppression; PD, progressive disease; PIK3CA, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; SmPC, summary of product characteristics; TT, targeted therapy.

References:

  1. KISQALI® (ribociclib) Summary of Product Characteristics.

  2. Cardoso F, et al. Ann Oncol 2020;31(12):1623–1649.

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

  4. McAndrew NP, et al. JCO Oncol Prac 2021;18(5):319–327.

  5. Slamon DJ, et al. Annals Oncol 2021;32(8):1015–1024.

  6. European Society for Medical Oncology. Metastatic Breast Cancer Living Guideline v1.2 April 2025. Available at: https://www.esmo.org/guidelines/living-guidelines/esmo-living-guideline-metastatic-breast-cancer/hr-positive-her2-negative-metastatic-breast-cancer [November 2025].

  7. Gennari A, et al. Ann Oncol 2021;32(12):1475–1495.

  8. Sonke GS, et al. Nature 2024;636:474–480.

  9. European Society for Medical Oncology. Ribociclib. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmomcbs-scorecards?mcbs_score_cards_form%5BsearchText%5D=ribociclib [Accessed November 2025].

  10. European Society for Medical Oncology. ESMO-magnitude of clinical benefit scale. Available at: https://www.esmo.org/content/download/288502/5736211/1/esmo-mcbs-booklet.pdf [Accessed November 2025].

UK | November 2025 | 442231-1

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.