ReviewInvestigational new drugs2013
Differences in drug approval processes of 3 regulatory agencies: a case study of gemtuzumab ozogamicin.
Review in Investigational new drugs, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
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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
13 citing papers in PubMed, 38 citations in OpenAlex.
- Tubulin inhibitors: an insight into new strategies to combat leukemia.Future medicinal chemistry · 2025Review
- US FDA-accelerated approvals and subsequent withdrawals: influence on Japanese clinical oncology practice guidelines.Investigational new drugs · 2025Article
- Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals.Clinical and translational science · 2024Article
- Pharmacovigilance for rare diseases: a bibliometrics and knowledge-map analysis based on web of science.Orphanet journal of rare diseases · 2023Review
- A critical appraisal of Japan's new drug approval process: a case study of FLT3-ITD inhibitor quizartinib.Investigational new drugs · 2021Article
- Mechanisms contributing to ado-trastuzumab emtansine-induced toxicities: a gateway to better understanding of ADC-associated toxicities.Antibody therapeutics · 2021Review
- Antibody-Drug Conjugates: The New Frontier of Chemotherapy.International journal of molecular sciences · 2020Review
- Effect and safety of gemtuzumab ozogamicin for the treatment of patients with acute myeloid leukaemia: a systematic review protocol.BMJ open · 2020Article
- Article
- Gemtuzumab ozogamicin in acute myeloid leukemia.Leukemia · 2017Review
- Article
- A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in Japan.Drug design, development and therapy · 2015Review
- Does technique matter; a pilot study exploring weighting techniques for a multi-criteria decision support framework.Cost effectiveness and resource allocation : C/E · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Major discrepancies concerning risk-benefit assessments and regulatory actions are frequent among regulatory agencies. We explored the differences by scrutinizing a case of gemtuzumab ozogamicin (GO) in patients with acute myeloid leukaemia (AML). Assessment reports of GO were retrieved form the websites of the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japanese regulatory agency, and we also reviewed published clinical trials. While GO was approved by the US FDA under the accelerated approval program in 2000, it was withdrawn from the market in 2010, based on the required post-marketing commitment failure. The EMA refused granting marketing authorization for GO in 2008 on the grounds that there were no randomised controlled trials (RCTs). GO was approved as an orphan drug in Japan in 2005, and the Japanese regulatory authority decided to continue with the approval in 2010 on the condition that post-marketing surveillance is strengthened. Under these situations, promising new results of RCTs appeared in 2011, and the role of GO in AML treatment was refocused worldwide. The stringent regulation may not be suitable in case of an orphan drug of targeted therapy, and more room should be kept to facilitate effective developments of new anti-neoplastic agents.
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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.