The Lacuna Project

lacuna (n.) a gap in a record where something should be

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Exhibit 129

Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval

Exhibit 129 · Peer-reviewed study

Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval

Among 46 indications with more than 5 years of follow-up (approved 2013-2017), approximately two-thirds (29, 63%) were converted to regular approval, 10 (22%) were withdrawn, and 7 (15%) remained ongoing after a median of 6.3 years.

Followed 46 cancer drug–indication pairs granted accelerated approval in 2013–2017 for more than five years. Twenty showed an overall survival or quality-of-life benefit in confirmatory trials. Nine were converted to regular approval without either, ten were withdrawn, and seven remained pending at the data cutoff.

Source
Ian T. T. Liu, Aaron S. Kesselheim and Edward R. Scheffer Cliff, JAMA
Date
April 2024
Quoted from
Abstract, Results (JAMA 2024;331(17):1471-1479; PubMed PMID 38583175)
Grade
Peer-reviewed
Document
https://doi.org/10.1001/jama.2024.2396
Accessed
2026-11-09
Cited by
Findings citing this exhibit
Note
The counts are drug–indication pairs, not distinct molecules.

Cited by

Finding MED-6.2
Primary record Under accelerated approval, FDA licenses drugs before their clinical benefit is shown, and confirmation has taken years while patients and public insurers paid for the drugs.