Evidence map›Paper›PMID 33632926›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2021

FDA Approval Summary: Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia with a

E Dianne Pulte, Kelly J Norsworthy, Yaping Wang, Qing Xu, Hisham Qosa, Ramadevi Gudi, Donna Przepiorka, Wentao Fu, Olanrewaju O Okusanya, Kirsten B Goldberg and 3 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed
8.6field-weighted citation impact, top 2% 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

46 citing papers in PubMed, 76 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. The best laid schemes...Haematologica · 2026
    Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. FDA Approval Summary: Olutasidenib for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase 1 Mutation.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Article
  18. Review
  19. Review
  20. Article
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

13 authors at 2 institutions in 1 country.

E Dianne PulteCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland. Elizabeth.pulte@fda.hhs.gov.
Kelly J NorsworthyCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.ORCID 0000-0002-8462-9994
Yaping WangCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Qing XuCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Hisham QosaCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Ramadevi GudiCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Donna PrzepiorkaCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Wentao FuCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Olanrewaju O OkusanyaCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Kirsten B GoldbergOncology Center of Excellence, FDA, Silver Spring, Maryland.ORCID 0000-0001-8659-1240
R Angelo De ClaroCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Ann T FarrellCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Richard PazdurOncology Center of Excellence, FDA, Silver Spring, Maryland.
Center for Drug Evaluation and Research · USUnited States Food and Drug Administration · US

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

On November 28, 2018, the FDA approved gilteritinib (Xospata; Astellas), a small-molecule FMS-like tyrosine kinase 3 (FLT3) inhibitor, for treatment of relapsed or refractory acute myeloid leukemia with a

Indexed as

Leukemia, Myeloid, AcutePosterior Leukoencephalopathy SyndromeAniline Compoundsfms-Like Tyrosine Kinase 3HumansMutationPyrazinesAniline CompoundsFLT3 protein, humanfms-Like Tyrosine Kinase 3gilteritinibPyrazines

Identifiers

PMID33632926
PMCPMC8506653
OpenAlexW3132740458

What OpenQuestion holds

Textmetadata
LicenceTDM
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.