ArticleCancer medicine2024
An empirical analysis of overall survival in drug approvals by the US FDA (2006-2023).
Article in Cancer medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed.
- Gemogenovatucel-T Advantage in Clonal Tumor Mutation Burden-High Ovarian Cancer.JCO precision oncology · 2026Trial
- Navigating the Prescription Drug Information System.Clinical pharmacology and therapeutics · 2026Review
- Deep-Learning Serial CT Prediction of Survival in Immunotherapy-Treated Non-Small Cell Lung Cancer.JAMA network open · 2026Article
- Association of haematological cancer drugs recommendation levels in Chinese Society of Clinical Oncology guideline with different approval approaches: a cross-sectional study.BMJ public health · 2026Article
- Comparison of the conditional approvals for anticancer drugs supported by single-arm trials in China and the United States: clinical evidence, post-marketing requirements, and regulatory outcomes.Frontiers in pharmacology · 2026Article
- Challenges in employing overall survival as a primary outcome in ovarian cancer studies: insights from PARP inhibitor trials.Frontiers in oncology · 2026Article
- Bayesian interim analysis and efficiency of phase III randomized trials.British journal of cancer · 2025Article
- Reply to 'Surrogate end points in oncology: aligning drug development incentives and patient needs'.Nature reviews. Clinical oncology · 2025Article
- Surrogate end points in oncology: aligning drug development incentives and patient needs.Nature reviews. Clinical oncology · 2025Article
- Surrogate end points in oncology: the speed-uncertainty trade-off from the patients' perspective.Nature reviews. Clinical oncology · 2025Article
- Trends in complexity of single-agent and combination therapies for solid tumor cancers approved by the US Food and Drug Administration.The oncologist · 2025Article
- Recent FDA-approved kinase inhibitors for cancer therapy in 2025: A comprehensive review and perspectives.EXCLI journal · 2025Review
- Frequently asked questions on surrogate endpoints in oncology-opportunities, pitfalls, and the way forward.EClinicalMedicine · 2024Review
- An empirical analysis of overall survival in drug approvals by the US FDA (2006-2023).Cancer medicine · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
backgroundThe US Food and Drug Administration (FDA) has expanded the use of surrogate markers in drugs approved for oncology/hematology indications. This has likely resulted in a greater number of approvals and possibly drugs coming to market faster, but it is unknown whether these drugs also improve overall survival (OS) for patients taking them.
methodsWe sought to estimate the percentage of oncology drugs that have shown to improve OS in a cross-sectional analysis of US FDA oncology drug approvals (2006-2023). We searched for OS data in registration trials and the peer-reviewed literature.
resultsWe found 392 oncology drug approvals. Eighty-seven (22%) drug approvals were based on OS, 147 drug approvals were later tested for OS benefit (38% of all approvals and 48% of drugs approved on a surrogate), and 130 (33%) have yet to be tested for OS benefit. Of the 147 drug approvals later tested for OS, 109 (28% of all approvals and 74% of drugs later tested for OS) have yet to show OS benefit, whereas 38 (10% of all approvals and 26% of drugs later tested for OS benefit) were later shown to have OS benefit. In total, 125 out of 392 (32%) drugs approved for any indication have been shown to improve OS benefit at some point, and 267 (68%) have yet to show approval.
conclusionAbout 32% of all oncology drug approvals have evidence for an improvement in OS. Higher standards are needed in drug regulation to ensure that approved drugs are delivering better patient outcomes, specifically in regards to survival.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.