Evidence map›Paper›PMID 29650683›Full record

ArticleThe oncologist2018

FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia.

Kelly J Norsworthy, Chia-Wen Ko, Jee Eun Lee, Jiang Liu, Christy S John, Donna Przepiorka, Ann T Farrell, Richard Pazdur

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The oncologist, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 146 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
146citing papers in PubMed, 2 pooled it
13.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

146 citing papers in PubMed, 2 syntheses or guidelines pooled it, 245 citations in OpenAlex.

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  16. Antibody-Empowered Nanomedicine for Precise Biomedical Applications.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
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86 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Kelly J NorsworthyCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA kelly.norsworthy@fda.hhs.gov.
Chia-Wen KoCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Jee Eun LeeCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Jiang LiuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Christy S JohnCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Donna PrzepiorkaCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Ann T FarrellCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Richard PazdurCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Center for Drug Evaluation and Research · USUnited States Food and Drug Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

On September 2, 2017, the U.S. Food and Drug Administration approved gemtuzumab ozogamicin (GO; Mylotarg; Pfizer, New York City, NY) for treatment of relapsed or refractory (R/R) CD33-positive acute myeloid leukemia (AML) in patients 2 years of age and older. GO is a CD33-directed antibody drug conjugate linked to the cytotoxic antibiotic calicheamicin. It originally received accelerated approval for treatment of older patients with relapsed CD33-positive AML in 2000, but it was withdrawn from the market in 2010 when the confirmatory trial failed to demonstrate clinical benefit among safety concerns, such as a higher rate of induction fatalities on the GO combination arm compared with chemotherapy alone. In addition, GO was associated with hepatic veno-occlusive disease (VOD), which has substantial morbidity and mortality. Pharmacokinetic analyses suggested a lower maximum concentration of GO would result in less VOD without affecting target saturation or efficacy. A meta-analysis across dose schedules of GO in patients with R/R AML showed that a lower-dose "fractionated" schedule of 3 mg/m IMPLICATIONS FOR PRACTICE: Gemtuzumab ozogamicin (GO) 3 mg/m

Indexed as

AdultAgedAged, 80 and overAminoglycosidesAntibodies, Monoclonal, HumanizedGemtuzumabHumansLeukemia, Myeloid, AcuteMiddle AgedSialic Acid Binding Ig-like Lectin 3United StatesUnited States Food and Drug AdministrationYoung AdultAminoglycosidesAntibodies, Monoclonal, HumanizedCD33 protein, humanGemtuzumabSialic Acid Binding Ig-like Lectin 3Acute myeloid leukemiaGemtuzumab ozogamicinMylotargU.S. Food and Drug Administration approval

Identifiers

PMID29650683
PMCPMC6192608
OpenAlexW2798249412

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.