# Conditional approvals that lapse automatically if the confirmatory trial is late

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

## TL;DR

Drugs given accelerated or conditional approval on surrogate endpoints have often stayed on the market for years after the confirmatory trial stalled or failed. The approval would lapse automatically if the sponsor missed agreed enrolment milestones or the readout date, unless an independent panel granted a documented extension.

## Summary

Accelerated and conditional approvals have often stayed on the market for years after confirmatory trials stalled or failed (the 'dangling' approvals reviewed in 2021). The FDORA 2022 reforms gave FDA power to require confirmatory trials to be underway and to expedite withdrawal; the EU renews conditional authorisations annually. The proposal is a self-executing sunset: at approval, the sponsor agrees enrolment milestones and a readout date, and the authorisation lapses without further procedure if the milestones are missed, unless an independent panel grants a documented extension.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Under an automatic sunset, the median time from accelerated approval to confirmatory readout falls below four years and the share of accelerated oncology indications still unconfirmed at five years falls below 10%, without a fall in the number of accelerated approvals granted.
- Rationale: Sponsors currently face weak incentives to complete confirmatory trials quickly because the drug is already earning revenue. A credible, non-discretionary deadline shifts the incentive; regulators would no longer need to spend years negotiating voluntary withdrawals.
- Proposed test: Apply the sunset to all new accelerated oncology approvals in one jurisdiction for five years and compare time to confirmation and withdrawal rates with the previous five-year cohort.
- Maturity: early-clinical
- Actor: regulator

## Sources

- Bottleneck evidence (Regulatory divergence between regions): FDA Oncology Center of Excellence, Project Orbis: https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis

## Connected records

- collections: [FDA Oncology Approvals (OCE) & Novel Drug Approvals](https://onco.cc/collections/fda-approvals/)
- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/)
- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)
- roadmaps: [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/idea-reg-conditional-approval-sunset.json