1. Medicines
  2. Oncology
  3. KISQALI®▼ (ribociclib)
  4. Premenopausal women

Prescribing information

 

Please note that the black triangle (▼) and associated additional monitoring activities required for Kisqali®, only applies to its marketing authorisation in Great Britain. It is NOT applicable to the marketing authorisation of Kisqali® in Northern Ireland.

 

PREMENOPAUSAL WOMEN WITH aBC HAVE INDIVIDUAL NEEDS:

  • They face a worse prognosis and more aggressive cancer than postmenopausal women1,2
  • Quality of life can be a challenge to maintain3

 

Extend the moment for premenopausal women with HR+/HER2− aBC

 

KISQALI + ET* is the only CDK4/6i to show statistically significant improvements in OS in three phase III trials4–7

 

 

*KISQALI is not recommended to be used in combination with tamoxifen.8

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 in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.8

 

KISQALI + ET* (along with other CDK4/6 inhibitors) is recognised by ESMO as a standard of care for aBC patients9–12

KISQALI + ET* in premenopausal women with HR+/HER2− aBC is the only CDK4/6 inhibitor recognised by ASCO Clinical Cancer Advances 202013

 

GIVING MORE TIME

Find out more about the MONALEESA-7 trial design and efficacy

 

CONFIDENCE IN KISQALI

Learn about QoL outcomes

 

MONALEESA-7: N=672, double-blind, placebo-controlled, 1:1 randomisation phase III trial in premenopausal women with HR+/HER2− aBC. As 1L in advanced disease and in patients who received 1 or fewer lines of chemotherapy for aBC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen 20 mg orally once daily continuously + LHRH agonist (goserelin 3.6 mg subcutaneously on day 1 of every cycle).4,7

1L, first line; aBC, advanced breast cancer;  AI, aromatase inhibitor; ASCO, American Society of Clinical Oncology; CDK4/6, cyclin-dependent kinase 4 and 6; ESMO, European Society for Medical Oncology; ET, endocrine therapy; HR+/HER2−, hormone receptor-positive/human epidermal growth factor receptor 2-negative; LHRH, luteinising hormone-releasing hormone; NSAI, non-steroidal aromatase inhibitor; OS, overall survival; QoL, quality of life. 

  1. Bardia A and Hurvitz S. Clin Cancer Res. 2018;24(21):5206–5218.
  2. Azim Jr HA and Partridge AH. Breast Cancer Res. 2014;16:427.
  3. Harbeck N, et al. Ther Adv Med Oncol. 2020;12:1758835920943065.
  4. Im S-A, et al. N Engl J Med. 2019;381(4):307–316.
  5. Finn RS, et al. Breast Cancer Res Treat. 2020;183:419–428.
  6. Goetz MP, et al. J Clin Oncol. 2017;35(32):3638–3646.
  7. Hortobagyi GN, et al. N Engl J Med. 2022;386(10):942–950.
  8. KISQALI (ribociclib). Summary of Product Characteristics.
  9. ESMO. ESMO-MCBS scorecards. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard.... Accessed June 2021.
  10. ESMO. ESMO-MCBS evaluation forms V1.0 & V1.1. Available at: https://www.esmo.org/guidelines/esmo-mcbs/scale-evaluation-forms-v1.0-v1.1. Accessed June 2021.
  11. ESMO. ESMO-MCBS V1.1. Updated September 2017. Available at: https://www.esmo.org/content/download/117394/2059186/. Accessed June 2021.
  12. Cardoso F. Highlights from ABC5. Presented at ESO e-Learning Session 511, 23 March 2020.
  13. Markham MJ, et al. J Clin Oncol. 2020;38(10:1081–1101.
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UK | April 2022 | 126170-1
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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 via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
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