Healthcare decision-making for tumour-agnostic therapies in Europe: lessons learned DOI Creative Commons
Milou A. Hogervorst,

Christine C. van Hattem,

Gabe S. Sonke

et al.

Drug Discovery Today, Journal Year: 2024, Volume and Issue: 29(7), P. 104031 - 104031

Published: May 23, 2024

The tumour-agnostic authorisations of larotrectinib and entrectinib shifted the paradigm for indication setting. European healthcare decision-makers agreed on their therapeutic potential but diverged primarily in identified uncertainties concerning basket trial designs endpoints, prognostic value neurotrophic tropomyosin receptor kinase (NTRK) gene fusions, resistance mechanisms. In addition, assessments relevant comparators, unmet medical needs (UMNs), implementation NTRK-testing strategies diverged. particular, tumour-specific reimbursement recommendations guidelines do not reflect thinking. These differences indicate difficulties experienced these provide valuable lessons future disruptive therapies. As we discuss here, early multistakeholder dialogues minimum evidence requirements involving clinicians are essential.

Language: Английский

Trastuzumab-Deruxtecan: Redefining HER2 as a Tumor Agnostic Biomarker DOI
Joseph Zouein, Elias Karam, John H. Strickler

et al.

Targeted Oncology, Journal Year: 2024, Volume and Issue: 19(5), P. 705 - 710

Published: July 4, 2024

Language: Английский

Citations

4
Healthcare decision-making for tumour-agnostic therapies in Europe: lessons learned DOI Creative Commons
Milou A. Hogervorst,

Christine C. van Hattem,

Gabe S. Sonke

et al.

Drug Discovery Today, Journal Year: 2024, Volume and Issue: 29(7), P. 104031 - 104031

Published: May 23, 2024

The tumour-agnostic authorisations of larotrectinib and entrectinib shifted the paradigm for indication setting. European healthcare decision-makers agreed on their therapeutic potential but diverged primarily in identified uncertainties concerning basket trial designs endpoints, prognostic value neurotrophic tropomyosin receptor kinase (NTRK) gene fusions, resistance mechanisms. In addition, assessments relevant comparators, unmet medical needs (UMNs), implementation NTRK-testing strategies diverged. particular, tumour-specific reimbursement recommendations guidelines do not reflect thinking. These differences indicate difficulties experienced these provide valuable lessons future disruptive therapies. As we discuss here, early multistakeholder dialogues minimum evidence requirements involving clinicians are essential.

Language: Английский

Citations

3