|| Breast Cancer
|| 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)
|| 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 
Complete information about Kisqali (ribociclib) dosage and administration can be found here: .The standard dosage is:
Consult your treating doctor for personalised dosing.
- 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.
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 .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 .
What is ribociclib's approval status?
Kisqali (ribociclib) was approved by:
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 .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 .Most common adverse reactions (incidence ≥ 20%) are low levels of white blood cells, nausea, fatigue, diarrhea, alopecia, vomiting, constipation, headache, and back pain .
- FDA (USA) on March 13, 2017 
- EMA (EU) on August 22, 2017 
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