# Make post-progression sampling a condition of accelerated approval

Source: https://onco.cc/ideas/idea-bio1-approval-linked-progression-sampling/  
OnCo record `idea-bio1-approval-linked-progression-sampling` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Drugs approved on early evidence come with follow-up obligations. One of them should be finding out how tumours escape the new drug.

## Summary

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Approval-linked sampling commitments produce mechanism data for new agents years earlier than the status quo and demonstrably shape the design of successor agents and combinations.
- Rationale: Post-marketing requirements are an established regulatory instrument and are already used for dose optimisation under Project Optimus; the incremental cost to a sponsor is small relative to the value of the information.
- Proposed test: Apply the requirement to a small number of new approvals as a pilot and compare time-to-first-published-mechanism with matched historical approvals.
- Maturity: speculative
- Actor: regulator

## Sources

- Bottleneck evidence (Acquired resistance to every therapy): Soria et al., Osimertinib in untreated EGFR-mutated NSCLC (FLAURA, NEJM 2018): https://doi.org/10.1056/NEJMoa1713137

## Connected records

- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [Drug resistance (primary and acquired)](https://onco.cc/terms/resistance/)
- bottlenecks: [Acquired resistance to every therapy](https://onco.cc/bottlenecks/b-resistance/), [Failures are hidden](https://onco.cc/bottlenecks/b-negative-results/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)

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