Evidence map›Paper›PMID 32007196›Full record

ReviewThe Lancet. Oncology2020

CAR T-cell product performance in haematological malignancies before and after marketing authorisation.

Magdi Elsallab, Bruce L Levine, Alan S Wayne, Mohamed Abou-El-Enein

Open access · greenAbstract readReview
In one paragraph

Review in The Lancet. Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 2 pooled it
4.9field-weighted citation impact, top 4% 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

49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 79 citations in OpenAlex.

  1. Pooled it
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  8. Redefining quality in cell and gene therapies: Lessons from implementing electronic QMS in academic cGMP facility.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
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  14. mRNA-based cancer therapeutics.Nature reviews. Cancer · 2023
    Review
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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

4 authors at 3 institutions in 2 countries.

Magdi ElsallabBerlin Institute of Health Center for Regenerative Therapies, Charité-Universitatsmedizin Berlin, Berlin, Germany.
Bruce L LevineCenter for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Alan S WayneChildren's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Los Angeles, CA, USA; Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Mohamed Abou-El-EneinBerlin Institute of Health Center for Regenerative Therapies, Charité-Universitatsmedizin Berlin, Berlin, Germany; Berlin Center for Advanced Therapies, Charité-Universitatsmedizin Berlin, Berlin, Germany. Electronic address: mohamed.abou-el-enein@charite.de.
Berlin Institute of Health at Charité - Universitätsmedizin Berlin · DEUniversity of Pennsylvania · USUniversity of Southern California · US

Funding

USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Fumito Ito · 1985 to 2026
$181.4M
NCI NIH HHS P30 CA014089
6 · The paper itself

Abstract

Chimeric antigen receptor (CAR) T cells represent a potent new approach to treat haematological malignancies. Two CAR T-cell therapies, tisagenlecleucel and axicabtagene ciloleucel, have been approved in Europe and the USA, as well as several other countries, for the treatment of leukaemia and lymphoma. These approvals marked a major milestone in the field of cell and gene therapies. However, the clinical development and regulatory evaluation of these innovative therapies faced several challenges that are considered important lessons learned for future similar products. Here, we examine the products' non-clinical and clinical data packages to outline the challenges encountered during the regulatory evaluation process in Europe, and to provide an update on their performance after authorisation.

Indexed as

Antigens, CD19Biological ProductsEuropeHematologic NeoplasmsHumansImmunotherapy, AdoptiveLegislation, DrugMarketingReceptors, Antigen, T-CellAntigens, CD19axicabtagene ciloleucelBiological ProductsReceptors, Antigen, T-Celltisagenlecleucel

Identifiers

PMID32007196
PMCPMC7841982
OpenAlexW3003764567

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.