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Some drugs work on a genetic change whatever the cancer. When one regulator approves such a label, others should adopt it rather than demanding trials per cancer type.
Tumour-agnostic approvals (NTRK fusions, MSI-high, BRAF V600E, RET) rest on basket trials that some regulators have accepted and others have restricted to specific tumour types, producing labels that differ by region for the same evidence. Patients with rare tumours in restrictive regions are excluded. The proposal is a standing agreement that tumour-agnostic indications granted by one stringent regulator on basket-trial evidence are adopted by partners within 90 days, with a shared post-marketing registry to fill evidence gaps in rare histologies.
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 Basket, umbrella, and platform trials, Regulatory divergence between regions, Rare and paediatric cancers without markets.
Shares Regulatory divergence between regions, Rare and paediatric cancers without markets.
Shares Basket, umbrella, and platform trials, Regulatory divergence between regions, Rare and paediatric cancers without markets.
Shares Basket, umbrella, and platform trials, Rare and paediatric cancers without markets.
Shares Regulatory divergence between regions, Rare and paediatric cancers without markets.
Shares Tumour-agnostic (tissue-agnostic) approval, Regulatory divergence between regions.