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Indications:1,2
- KISQALI® (ribociclib) is indicated for the treatment of women with hormone receptor (HR)-positive (HR+), 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
KISQALI is not recommended to be used in combination with tamoxifen.1,2
The NCCN is a not-for-profit alliance of 33 leading US cancer centres, used in more than 180 countries.3
NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®): Breast Cancer
NCCN recommendations for KISQALI in HR+/HER2– recurrent, unresectable or stage IV (M1) breast cancer:4
Both KISQALI + AI and KISQALI + fulvestrant are Category 1, preferred regimens for first-line treatment4
No other CDK4/6 inhibitor + AI is listed as Category 1 for first-line treatment*4
Other CDK4/6 inhibitors are Category 1, preferred regimens when given in combination with fulvestrant4
KISQALI + fulvestrant is also a Category 1, preferred regimen for second- and subsequent-line treatment if a CDK4/6 inhibitor has not been previously used4
How are the NCCN guidelines developed and updated?5
- Recommendations are derived from critical evaluation of evidence, integrated with the clinical expertise and consensus of a multidisciplinary panel of experts and researchers
- Panels evaluate the efficacy and toxicity of interventions
- Recommendations are agreed upon by panel members
- NCCN categories for recommendations are based on the level of clinical evidence available and the degree of consensus within the panel
View the table below to learn more about the NCCN categories of evidence and consensus.
|
Category 1 |
Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate |
|
Category 2A |
Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate |
|
Category 2B |
Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate |
|
Category 3 |
Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate |
*KISQALI is not recommended to be used in combination with tamoxifen.1,2
aBC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; HER2–, human epidermal growth receptor 2 negative; HR+, hormone receptor positive; LHRH, luteinising hormone-releasing hormone; NCCN, National Comprehensive Cancer Network.
References:
- KISQALI (ribociclib). GB Summary of Product Characteristics.
- KISQALI (ribociclib). NI Summary of Product Characteristics.
- National Comprehensive Cancer Network. Available at: https://www.nccn.org/ [Accessed February 2024].
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer Version 1.2024. National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Available at: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1419 [Accessed February 2024]. To view the most recent and complete version of the guideline, go online to NCCN.org.
- National Comprehensive Cancer Network. Development and Update of Guidelines. Available at: https://www.nccn.org/guidelines/guidelines-process/development-and-updat... [Accessed February 2024].