WEBPatients with moderate (Child-Pugh class B) and severe hepatic impairment (Child-Pugh class C) can have increased (less than 2-fold) exposure to ribociclib and the starting dose of 400 mg Kisqali once daily is recommended (see section 5.2).
FDA approves ribociclib with an aromatase inhibitor and ribociclib …
WEB5 days ago · Efficacy of ribociclib with a non-steroidal aromatase inhibitor (NSAI) was evaluated in NATALEE (NCT03701334), a randomized, open-label, multicenter trial in 5101 adults with HR-positive, HER2 ...
Kisqali - European Medicines Agency (EMA)
WEBAug 31, 2017 · The active substance in Kisqali, ribociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which are important for regulating the way cells grow and divide. By blocking CDK4 and CDK6, Kisqali slows the growth of HR-positive breast cancer cells.
WEBKISQALI is a kinase inhibitor indicated for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or.
Ribociclib plus Endocrine Therapy in Early Breast Cancer
WEBMar 20, 2024 · Ribociclib plus an NSAI significantly improved invasive disease–free survival among patients with HR-positive, HER2-negative stage II or III early breast cancer. (Funded by Novartis; NATALEE...
New Kisqali® data shows consistent overall survival benefit across ...
WEBDec 8, 2021 · Hortobagyi, et al. Overall survival (OS) results from the phase III MONALEESA (ML)-2 trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib.
Kisqali (ribociclib) dosing, indications, interactions, adverse effects ...
WEBMedscape - Breast cancer dosing for Kisqali (ribociclib), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information.
Ribociclib as First-Line Therapy for HR-Positive, Advanced …
WEBNov 3, 2016 · Ribociclib (LEE011) is an orally bioavailable, selective, small-molecule inhibitor of CDK4/6 that blocks the phosphorylation of retinoblastoma protein, thereby preventing cell-cycle progression...
Real-World Evidence of Ribociclib Plus Aromatase Inhibitors as …
WEBApr 11, 2024 · Ribociclib is a cyclin-dependent kinase 4/6 inhibitor whose efficacy and safety have been proven through a robust series of phase III randomized clinical trials (RCTs) called MONALEESA. Knowledge generated by the BrasiLEEira study shows that progression-free survival at 12 months was 77.6% among included patients, a rate higher than that in the ...
Ribociclib Combo Yields Extended iDFS Benefit in HR+/HER2– …
WEB6 days ago · Combining ribociclib (Kisqali) with nonsteroidal aromatase inhibitor (NSAI) therapy demonstrated sustained improvements in invasive disease-free survival (iDFS) and distant disease-free survival (DDFS) vs NSAI alone among patients with hormone receptor (HR)–positive, HER2-negative early breast cancer, according to 4-year landmark analysis data from the phase 3 NATALEE trial (NCT03701334 ...