Prescribing information


  • They typically 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 trials4–6

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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.7


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KISQALI + ET* (along with other CDK4/6 inhibitors) is recognised by ESMO as a standard of care for HR+/HER2− aBC patients8,9

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KISQALI + ET* in premenopausal women with HR+/HER2− aBC is the only CDK4/6 inhibitor recognised by ASCO Clinical Cancer Advances 202010


*KISQALI is not recommended to be used in combination with tamoxifen.7



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



Learn about QoL outcomes


MONALEESA-7: N=672, double-blind, placebo-controlled, 1:1 randomisation, phase III trial in pre- and perimenopausal 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) + NSAI (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).11

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. Hortobagyi GN, et al. N Engl J Med. 2022;386(10):942–950.
  6. Slamon DJ, et al. N Engl J Med. 2020;382(6):514–52.
  7. KISQALI (ribociclib). Summary of Product Characteristics.
  8. ESMO. ESMO-MCBS scorecards. Available at: [Accessed August 2022]
  9. Cardoso F, et al. Ann Oncol. 2020; 31(12): 1623–1649.
  10.  Markham MJ, et al. J Clin Oncol. 2020;38(10):1081–1101.
  11. Tripathy D, et al. Lancet Oncol 2018; 19:904–915.
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UK | August 2022 | 126170-2

Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]