ReviewNature reviews. Clinical oncology2022
An appraisal of FDA approvals for adult solid tumours in 2017-2021: has the eagle landed?
Review in Nature reviews. Clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 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
20 citing papers in PubMed.
- Assessing Overall Survival Benefits in Advanced Cancers: The Role of External Comparator Cohort Studies with Real-World Data.Clinical pharmacology and therapeutics · 2026Article
- Strategic risk assessment in oncology: Utilizing single-agent activity to boost combination therapy approvals.Contemporary clinical trials communications · 2026Article
- Temporal trends in evidence supporting novel drug target discovery.Nature communications · 2025Article
- Predictors of withdrawal of anticancer drug indications granted accelerated approval: a retrospective cohort study.EClinicalMedicine · 2025Article
- Review
- Factors in Time to Full Approval or Withdrawal for Anticancer Medicines Granted Accelerated Approval by the FDA.JAMA network open · 2025Article
- Characteristics, clinical evidence and implementation effects of conditional approvals for drugs in China, a pooled analysis from 2020 to 2023.Frontiers in pharmacology · 2025Article
- Evidence of clinical benefit of cancer medicines considered for funding in Australia.International journal of technology assessment in health care · 2024Article
- Critical Appraisal of Guideline Recommendations on Systemic Therapies for Advanced Hepatocellular Carcinoma: A Review.JAMA oncology · 2024Review
- Cancer medicines: a private vice for public benefit?Ecancermedicalscience · 2024Article
- The FDA's latest draft guidance on accelerated approvals - one step forward, two steps back?Nature reviews. Clinical oncology · 2023Article
- Global Cancer Drug Development-A Report From the 2022 Accelerating Anticancer Agent Development and Validation Meeting.JCO global oncology · 2023Article
- Cancer Drugs Reimbursed with Limited Evidence on Overall Survival and Quality of Life: Do Follow-Up Studies Confirm Patient Benefits?Clinical drug investigation · 2023Review
- National value-based pricing negotiation for oncology drugs - lessons from China.Nature reviews. Clinical oncology · 2023Article
- Costs and Causes of Oncology Drug Attrition With the Example of Insulin-Like Growth Factor-1 Receptor Inhibitors.JAMA network open · 2023Article
- Towards evidence-based response criteria for cancer immunotherapy.Nature communications · 2023Article
- Exploring a new pathway for biomarker-based approval of immunotherapies.Nature reviews. Clinical oncology · 2023Article
- Objective response rate of placebo in randomized controlled trials of anticancer medicines.EClinicalMedicine · 2023Article
- Predictive validity in drug discovery: what it is, why it matters and how to improve it.Nature reviews. Drug discovery · 2022Review
- Assessment of the clinical and cost-effectiveness evidence in the reimbursement decisions of new cancer drugs.ESMO open · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In 2016, the then US President Barack Obama announced the Cancer Moonshot with a view to making 10 years' worth of progress in cancer prevention, diagnosis and treatment in only 5 years. This Perspective evaluates the FDA approvals of therapeutic agents for use in solid tumour oncology for the period 2017-2021 against the aspirations of the Cancer Moonshot. In the past 5 years, the FDA issued an unprecedented 161 new approvals of therapeutic agents for various indications in adult patients with solid tumours. However, less than a third (27%) of the newly approved medicines are supported by unequivocal evidence of an overall survival benefit; most are supported by positive signals from surrogate end points. Herein, the European Society for Medical Oncology Magnitude of Clinical Benefit Scale version 1.1 was used to evaluate the clinical value of the therapies granted FDA approval during the period 2017-2021. The results of this appraisal indicate a low level of clinical benefit for a substantial proportion (~20%) of the new indications, with most (~44%) providing intermediate benefit. The data suggest that, beyond increases in the sheer quantity of approvals, considerable improvement in the quality of the approved treatments is required to more confidently ensure that the clinical benefits are real and substantial enough to clearly justify the risks to patients.
Indexed as
Identifiers
35484286What 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.