Predictors of withdrawal of anticancer drug indications granted accelerated approval: a retrospective cohort study
Ariadna Tibau; Edward R. Scheffer Cliff; Alejandra Romano; María Borrell; Consolación Moltó; Aaron Seth Kesselheim · 2025 · EClinicalMedicine
WASTE classifies this as Negative / Null Result Report · AI classification, approximate
The study found no significant effect — useful as a negative control or null benchmark for your own design.
Abstract
Background: The accelerated approval pathway allows the FDA to approve drugs for serious conditions based on promising surrogate measures, with confirmatory studies required later. If subsequent testing shows an unfavorable benefit-risk profile, the indication may be withdrawn. This study aimed to identify factors associated with the withdrawal of drug indications following accelerated approval. Methods: In this retrospective cohort study, we identified FDA-approved drugs for solid and hematologic cancers from 1992 to 2022 and extracted factors present at the time of accelerated approval, incl
Abstract by Ariadna Tibau; Edward R. Scheffer Cliff; Alejandra Romano; María Borrell; Consolación Moltó; Aaron Seth Kesselheim, EClinicalMedicine (2025) — licensed CC BY 4.0.
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Metadata source: OpenAlex · DOI 10.1016/j.eclinm.2025.103088