ArticleCancers2020
FDA and EMA Approvals of New Breast Cancer Drugs-A Comparative Regulatory Analysis.
Article in Cancers, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 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
17 citing papers in PubMed.
- Botanical Adjuvants in Oncology: A Review on Natural Compounds in Synergy with Conventional Therapies as Next-Generation Enhancers of Breast Cancer Treatment.Current issues in molecular biology · 2026Review
- Cardio-Oncology and Heart Failure: a Scientific Statement From the Heart Failure Society of America.Journal of cardiac failure · 2025Review
- Consensus Guidelines for the Use of Cyclin-Dependent Kinase (CDK) 4/6 Inhibitors in the Management of Hormone Receptor Positive (HR+ve), Her2-ve Early Breast Cancer (EBC).South Asian journal of cancer · 2025Article
- Failure to progress: breast and prostate cancer cell lines in developing targeted therapies.Cancer metastasis reviews · 2024Review
- Clinical development and marketing application review times for novel orphan-designated drugs.Frontiers in medicine · 2024Article
- Evidence into practice: a national cohort study of NICE-recommended oncological drug therapy utilisation among women diagnosed with invasive breast cancer in England.British journal of cancer · 2023Article
- Trends in endpoint use in pivotal trials and efficacy for US Food and Drug Administration-approved solid tumor therapies, 1995-2021.Journal of managed care & specialty pharmacy · 2022Review
- A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU.Clinical and translational science · 2022Article
- Review
- Computationally repurposing drugs for breast cancer subtypes using a network-based approach.BMC bioinformatics · 2022Article
- USE OF ARTIFICIAL CELLS AS DRUG CARRIERS.Materials chemistry frontiers · 2021Article
- Current Perspectives on Taxanes: Focus on Their Bioactivity, Delivery and Combination Therapy.Plants (Basel, Switzerland) · 2021Review
- Epigenetics in Breast Cancer Therapy-New Strategies and Future Nanomedicine Perspectives.Cancers · 2020Review
- Article
- Nursing Personnel in the Era of Personalized Healthcare in Clinical Practice.Journal of personalized medicine · 2020Review
- New Therapeutics in HER2-Positive Advanced Breast Cancer: Towards a Change in Clinical Practices?pi.Cancers · 2020Review
- Designing and Immunomodulating Multiresponsive Nanomaterial for Cancer Theranostics.Frontiers in chemistry · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Breast cancer is the most common cancer in women worldwide and the solid tumor type for which the highest number of drugs have been approved to date. This study examines new drug approvals for breast cancer by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), based on an analysis of regulatory documents from both agencies for the period from 1995 to 2018. Of the 29 breast cancer drugs approved over this time span, 17 received positive decisions from both the FDA and EMA, including all drugs licensed after 2008. Nineteen of the 25 FDA-approved drugs, but none of the EMA approvals, benefited from special regulatory pathways (such as fast track, breakthrough therapy, or priority review). In the U.S.A., four accelerated approvals were granted (of which one, for bevacizumab, was later revoked), while only two drugs received provisional approvals following EMA review. New breast cancer drugs were approved approximately twelve months earlier in the United States than in Europe. These results suggest that a broader use of special regulatory pathways by EMA could help to accelerate access to novel drugs for European breast cancer patients.
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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.