Active Ingredient: RIBOCICLIB
Ribociclib (a CDK4/6 inhibitor used in advanced breast cancer) is associated with a significantly increased risk of QTc interval prolongation. A meta-analysis of three Phase III randomized trials (n = 2062) demonstrated a pooled Risk Ratio of 7.96 (95% CI: 3.68-17.19) for a delta QTcF > 60ms from baseline. A post-baseline QTc > 480ms occurred in 5.3% of ribociclib-treated patients compared to 0.7% in control groups (pooled RR = 4.00). QTc prolongation frequently requires dose reduction, interruption, or treatment discontinuation (1.38% vs 0.33%). Baseline and frequent on-treatment ECG monitoring is mandatory.
https://doi.org/10.1016/j.ctrv.2025.103069, https://doi.org/10.1016/j.hemonc.2020.03.001, https://doi.org/10.1093/jncics/pkae078