ESMO: European Society for Medical Oncology

  1. It includes age and lung metastases as additional adverse prognostic factors and uses a single cut-off of LDH at 2.5× ULN 

  2. A new analysis from US show that response to genome-targeted therapy increased from 2.73% in 2006 to 7.04% in 2020

  3. Evidence for efficacy and safety is based on the results from the TROPHY study

  4. Approval is based on population pharmacokinetic modelling analyses

  5. Efficacy and safety were evaluated in the ASCENT study