Entrectinib (3) – Rozlytrek®

• Clinical trials
  • The STARTRK-NG trial is an ongoing, uncontrolled clinical study involving paediatric patients (from birth to < 18 years), which is divided into a dose-escalation phase and an expansion phase.
  • The TAPISTRY trial is an ongoing, uncontrolled, open-label platform trial with an umbrella design.
  • The STARTRK-2 trial is an ongoing, uncontrolled clinical study.

Paediatric patients (aged over one month to 12 years) with solid tumours harbouring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have locally advanced or metastatic disease, or a condition where surgical resection has a high probability of resulting in severe morbidity, and who have not previously received an NTRK inhibitor and for whom no satisfactory treatment options other than larotrectinib are available

• In summary, there are no suitable data available to enable an assessment of the additional benefit; therefore, the additional benefit of entrectinib is not proven.
• Overall assessment
  • In summary, there are no suitable data available to enable an assessment of the additional benefit; consequently, the additional benefit of entrectinib for the treatment of paediatric patients aged over 1 month with solid tumours harbouring an NTRK gene fusion, who have locally advanced or metastatic disease, or a condition where surgical resection has a high probability of resulting in severe morbidity, and who have not previously received an NTRK inhibitor and for whom no satisfactory treatment options are available, it is not proven.

Courtesy translation only, please refer to the German original.