Kisqali (ribociclib)

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Kisqali (ribociclib)

Manufacturer Novartis
Disease Breast Cancer
Indication HR-positive, HER2-negative advanced or metastatic breast cancer epidermal gro
Mode of Action Kinase inhibitor (targeted therapy)
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
Strength 200 mg

Who is ribociclib for?

Kisqali (ribociclib) is indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer [1][2].

Recommended dose

Complete information about Kisqali (ribociclib) dosage and administration can be found here: [1][2].
The standard dosage is:
  • 600 mg orally (three 200 mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment (one complete cycle consists of 28 days).
  • Dose interruption, reduction, and/or discontinuation may be required based on individual safety and tolerability.
Consult your treating doctor for personalised dosing.

What is ribociclib and how does it work?

Kisqali (ribociclib) is a kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer [1][2].
Ribociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6. Before a cell can divide, it has to go through four phases. The first phase is a growth phase (G1-phase), the second a synthesis phase (S-phase), the third another growth phase (G2-phase), and the last phase is where the cell divides (M-phase). Cancer cells divide exceedingly fast, passing through these 4 phases rapidly. Ribociclib blocks the progression from the first G1-phase, into the second S-phase. It does this by inhibiting the cyclin-dependent kinases 4 and 6 (CDK4 and CDK6)— two proteins that are involved in entering the S-phase [1].

What is ribociclib's approval status?

Kisqali (ribociclib) was approved by:
  • FDA (USA) on March 13, 2017 [3]
  • EMA (EU) on August 22, 2017 [4]
in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with HR-positive HER2-negative advanced or metastatic breast cancer.
The efficacy of Kisqali (ribociclib) was assessed in a randomised, double-blind, placebo-controlled, multicenter clinical study (MONALEESA-2) which compared ribociclib plus letrozole (N = 334) to placebo plus letrozole (N = 334) in a total of 668 postmenopausal women with HR-positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease [1][2].
The median progression-free survival (PFS) (at the 2/01/2017 cutoff) was 25.3 months ribociclib plus letrozole group (95 % CI: 23.0, 30.3) and 16.0 months (95 % CI 13.4, 18.2) in the placebo group. The overall response rate was 54.5 % in the ribociclib plus letrozole group (95 % CI: 48.4 , 60.6) and  38.8 % (95 % CI 32.7, 44.9) in the placebo plus letrozole group [2].
Most common adverse reactions (incidence ≥ 20%) are low levels of white blood cells, nausea, fatigue, diarrhea, alopecia, vomiting, constipation, headache, and back pain [1][4].
References
[1] Summary of Product Characteristics [FDA]: Kisqali (ribociclib), Novartis Pharmaceuticals Corporation, Mar. 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209092s000lbl.pdf
[2] Summary of Product Characteristics [EMA]: Kisqali (ribociclib), Novartis Europharm Ltd, Aug. 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004213/WC500233997.pdf
[3] FDA. Approved Drugs: Ribociclib (Kisqali), 13/03/2017.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm546438.htm
[4] EMA. Human Medicines: Kisqali (ribociclib). (last updated: 31/08/2017), cited on: 19/10/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004213/human_med_002149.jsp&mid=WC0b01ac058001d124

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.

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