Evidence map›Paper›PMID 36547666›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2023

Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia.

Kendra L Sweet, Jorge E Cortes, Jane F Apperley, Mel Mann, Michael J Mauro, Vivian G Oehler, Cristina Ruiz, Charles A Schiffer, Lori A Ehrlich, Gulsum E Pamuk and 6 more

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

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.5field-weighted citation impact, top 32% 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

6 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Project Confirm: Accelerated Drug Approvals for CML-Letter.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Article
  6. Project Confirm: Accelerated Drug Approvals for CML-Response.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 10 institutions in 3 countries.

Kendra L SweetMoffitt Cancer Center, Tampa, Florida.ORCID 0000-0001-6248-3317
Jorge E CortesGeorgia Cancer Center, Augusta University, Augusta, Georgia.ORCID 0000-0002-8636-1071
Jane F ApperleyCentre for Haematology, Imperial College, London, United Kingdom.ORCID 0000-0002-1710-1794
Mel MannPatient Advocate, Jonesboro, Georgia.ORCID 0000-0001-7847-6365
Michael J MauroMyeloproliferative Neoplasms Program, Memorial Sloan Kettering Cancer Center, New York City, New York.ORCID 0000-0002-2251-4032
Vivian G OehlerFred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle, Washington.ORCID 0000-0002-1630-4151
Cristina RuizPatient Advocate, Los Angeles, California.ORCID 0000-0001-7245-7980
Charles A SchifferDepartment of Hematology-Oncology, Karmanos Cancer Center at Wayne State University, Detroit, Michigan.ORCID 0000-0003-4188-7886
Lori A EhrlichCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC.ORCID 0000-0001-5981-1332
Gulsum E PamukCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC.ORCID 0000-0002-2299-3758
Joseph WynneCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC.ORCID 0000-0002-2079-4595
Gautam U MehtaCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC.ORCID 0000-0002-8009-6430
R Angelo de ClaroCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC.ORCID 0000-0001-8362-1977
Marc R TheoretOncology Center of Excellence, U.S. Food and Drug Administration, Washington, DC.ORCID 0000-0003-4973-5297
B Douglas SmithThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.ORCID 0000-0002-0903-7390
Kelly J NorsworthyCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC.ORCID 0000-0002-8462-9994
Center for Drug Evaluation and Research · USPatient Advocate Foundation · USAugusta University Health · USImperial College London · GBMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USSeattle Cancer Care Alliance · USSidney Kimmel Comprehensive Cancer Center · USThe Barbara Ann Karmanos Cancer Institute · USUnited States Food and Drug Administration · US

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

The FDA has an accelerated approval program for drugs that have been identified as promising treatments for serious conditions when the available data suggest that the benefits outweigh the foreseeable risks. All of the currently available treatment options for chronic myeloid leukemia (CML) initially went through the accelerated approval program. Here, a group of academic CML experts, patient panelists, and members from the FDA convened to discuss the utility of the accelerated approval program as it pertains to CML, and the utility of this program in future drug development in this disease. The results of that discussion are summarized here.

Indexed as

Drug ApprovalLeukemia, Myelogenous, Chronic, BCR-ABL PositiveHumansUnited StatesUnited States Food and Drug Administration

Identifiers

PMID36547666
PMCPMC10272032
OpenAlexW4312093617

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.