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Some drugs are approved for any cancer with a particular mutation. Clear rules on how many cancer types must be tested, and how to combine results across them, would make these approvals more consistent and faster.
Regulators publish a standard for tissue-agnostic evidence: a minimum number of histologies with a minimum number of evaluable patients each, a Bayesian hierarchical model for borrowing across histologies with pre-specified heterogeneity thresholds, and rules for excluding histologies that show no activity. Sponsors design basket trials to the standard, and approvals list the histologies supporting them.
Shares NTRK, RET, Tumour-agnostic (tissue-agnostic) approval, Basket, umbrella, and platform trials.
Shares NTRK, RET, Tumour-agnostic (tissue-agnostic) approval, Regulatory divergence between regions.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Basket, umbrella, and platform trials, Trial design, endpoints and cost.
Shares Basket, umbrella, and platform trials, Regulatory divergence between regions, Rare and paediatric cancers without markets, Trial design, endpoints and cost.
Shares Basket, umbrella, and platform trials, Regulatory divergence between regions, Rare and paediatric cancers without markets, Trial design, endpoints and cost.
Shares Basket, umbrella, and platform trials, Rare and paediatric cancers without markets, Trial design, endpoints and cost.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Trial design, endpoints and cost.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Trial design, endpoints and cost.