The Lacuna Project

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

Independent research. Not affiliated with any government, agency, or company.

Exhibit 098

Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval

Exhibit 098 · Regulatory cohort 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of follow-up (approved 2013-2017), approximately two-thirds (29, 63%) were converted to regular approval, 10 (22%) were withdrawn, and 7 (15%) remained ongoing after a median of 6.3 years.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, with records through 2023. Twenty demonstrated overall-survival or quality-of-life benefit; nine converted to regular approval without demonstrating either; ten were withdrawn; seven remained pending.

Source
Liu, Kesselheim and Cliff, JAMA
Date
2024
Quoted from
Abstract, Results (JAMA 2024;331(17):1471-1479; PubMed PMID 38583175)
Grade
Peer-reviewed
Document
https://jamanetwork.com/journals/jama/fullarticle/2817337
Accessed
2026-11-09
Cited by
Findings citing this exhibit
Note
DOI 10.1001/jama.2024.2396.

Cited by

Finding MED-4.4
Primary record Of 104 accelerated drug approvals with unfinished confirmatory trials in 2022, 35 had a trial past its original completion date. Medicare and Medicaid spent more than $18 billion on the 18 drugs involved from 2018 to 2021.