Repotrectinib (1) – Augtyro®

• Clinical trials
  • For the benefit assessment, the pharmaceutical manufacturer submits exclusively the results of the ongoing, single-arm, pivotal TRIDENT-1 (Phase 2) trial.

a) Adults and adolescents aged 12 years and over with advanced solid tumours that harbour a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and who have not previously received an NTRK inhibitor, and for whom treatment options not targeting NTRK offer limited clinical benefit or have been exhausted

• The additional benefit is not proven.
• These data are not suitable for assessing additional benefit, as there is no comparison with the appropriate comparator therapy.
• Overall assessment
  • For the benefit assessment, the pharmaceutical manufacturer has submitted only results from the single-arm TRIDENT-1 (Phase 2) study. These data are not suitable for assessing additional benefit, as there is no comparison with the appropriate comparator therapy. An additional benefit of repotrectinib is therefore not proven.

b) Adults and adolescents aged 12 years and over with advanced solid tumours harbouring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion who have previously received an NTRK inhibitor

• The additional benefit is not proven.
• These data are not suitable for assessing additional benefit, as there is no comparison with the appropriate comparator therapy.
• Overall assessment
  • For the benefit assessment, the pharmaceutical manufacturer has submitted only results from the single-arm TRIDENT-1 study (Phase 2). These data are not suitable for assessing additional benefit, as there is no comparison with the appropriate comparator therapy. An additional benefit of repotrectinib is therefore not proven.

Courtesy translation only, please refer to the German original.