ArticleClinical pharmacology and therapeutics2019
Pharmacokinetic/Pharmacodynamic Modeling to Support the Re-approval of Gemtuzumab Ozogamicin.
Article in Clinical pharmacology and therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 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
16 citing papers in PubMed, 35 citations in OpenAlex.
- Clinical Pharmacology and Translational Science Considerations in the Development of Dual-Payload Antibody Drug Conjugates.Clinical and translational science · 2026Review
- Applications of Pharmacometrics in Antibody-Drug Conjugate Development.Pharmaceutics · 2026Review
- Clinical application and optimization strategies for antibody-drug conjugates in solid tumors.The Journal of international medical research · 2026Review
- Review
- Application of Pharmacometrics in Advancing the Clinical Research of Antibody-Drug Conjugates: Principles and Modeling Strategies.Clinical pharmacokinetics · 2024Review
- Patient, industry, and regulatory perspective on antibody-drug conjugates dose optimization.Clinical and translational science · 2024Article
- A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development.Journal of pharmacokinetics and pharmacodynamics · 2023Review
- Antibody-drug conjugates in urinary tumors: clinical application, challenge, and perspectives.Frontiers in oncology · 2023Review
- An Elaborate New Linker System Significantly Enhances the Efficacy of an HER2-Antibody-Drug Conjugate against Refractory HER2-Positive Cancers.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2021Article
- Model-Informed Therapeutic Dose Optimization Strategies for Antibody-Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration-Approved Antibody-Drug Conjugates?Clinical pharmacology and therapeutics · 2021Review
- Acute myeloid leukemia: Therapy resistance and a potential role for tetraspanin membrane scaffolds.The international journal of biochemistry & cell biology · 2021Review
- Characterization of the Relationship of Inotuzumab Ozogamicin Exposure With Efficacy and Safety End Points in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia.Clinical and translational science · 2021Article
- Prevention, recognition, and management of adverse events associated with gemtuzumab ozogamicin use in acute myeloid leukemia.Journal of hematology & oncology · 2020Review
- CD markers polymorphisms as prognostic biomarkers in hematological malignancies.Oncology reviews · 2020Article
- Overexpression of annexin A5 might guide the gemtuzumab ozogamicin treatment choice in patients with pediatric acute myeloid leukemia.Therapeutic advances in medical oncology · 2020Article
- Gemtuzumab ozogamicin and novel antibody-drug conjugates in clinical trials for acute myeloid leukemia.Biomarker research · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Gemtuzumab ozogamicin (Mylotarg; Pfizer, New York, NY) was the first antibody-drug conjugate to be approved for CD33-positive acute myeloid leukemia (AML). However, it was voluntarily withdrawn from the US market due to lack of clinical benefit in the confirmatory phase III trial. In 2012, several investigator cooperative studies using a different dosing regimen showed efficacy, but pharmacokinetic (PK) data were not collected in these trials. Through simulation of expected concentrations for new dosing regimens, PK/pharmacodynamic modeling was able to support the safety and efficacy of these regimens. Significant exposure-response relationships were found for the attainment of complete remission with and without platelet recovery, attainment of blast-free status, the time course of myelosuppression, several grade ≥ 3 hepatic adverse events, and veno-occlusive disease. Gemtuzumab ozogamicin received full approval by the US Food and Drug Administration (FDA) in September 2017 for newly diagnosed and relapsed AML in adult patients and relapsed AML in pediatric patients aged 2-17 years.
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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.