Make post-progression sampling a condition of accelerated approval
Drugs approved on early evidence come with follow-up obligations. One of them should be finding out how tumours escape the new drug.
Accelerated approvals already carry confirmatory trial requirements. Adding a resistance-characterisation commitment (a specified number of paired progression samples with mechanism reporting into a public database within a defined period) would ensure the field learns how each new agent fails while the drug is still early in its lifecycle, rather than a decade later.
- Acquired resistance to every therapy · Nearly every targeted therapy stops working within months to a few years as the tumour adapts.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Failures are hidden · Negative trials, failed drugs and abandoned programmes are rarely published, so the same mistakes are repeated.
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not linked directly; found by shared links- IdeaSponsors deposit the confirmatory trial budget in escrow at accelerated approval
Shares Accelerated approval, Regulatory divergence between regions.
- IdeaCut off the emergency programme cancer cells use to survive treatment
Shares Drug resistance (primary and acquired), Acquired resistance to every therapy.
- IdeaPublish every complete response letter and negative opinion across all regulators
Shares Failures are hidden, Regulatory divergence between regions.
- IdeaConditional approvals that lapse automatically if the confirmatory trial is late
Shares Accelerated approval, Regulatory divergence between regions.
- ProductMelphalan flufenamide
Shares Accelerated approval, Failures are hidden.
- IdeaBlock the chemical switch that lets cells hide from treatment
Shares Drug resistance (primary and acquired), Acquired resistance to every therapy.
- IdeaProvisional prices for surrogate-endpoint approvals, reset when survival data arrive
Shares Accelerated approval, Regulatory divergence between regions.
- IdeaTurn off the error-prone repair that manufactures resistance mutations
Shares Drug resistance (primary and acquired), Acquired resistance to every therapy.