It includes age and lung metastases as additional adverse prognostic factors and uses a single cut-off of LDH at 2.5× ULN
A new analysis from US show that response to genome-targeted therapy increased from 2.73% in 2006 to 7.04% in 2020
Evidence for efficacy and safety is based on the results from the TROPHY study
Approval is based on population pharmacokinetic modelling analyses
Efficacy and safety were evaluated in the ASCENT study