Evidence map›Paper›PMID 35403693›Full record

ArticleThe oncologist2022

FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma.

Najat Bouchkouj, Megan Zimmerman, Yvette L Kasamon, Cong Wang, Tianjiao Dai, Zhenzhen Xu, Xiaofei Wang, Marc Theoret, Tejashri Purohit-Sheth, Bindu George

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 9% 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

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Mapping the clinical landscape of multifunctional CAR T cells: Targets, trends, and synergies.Molecular therapy : the journal of the American Society of Gene Therapy · 2026
    Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. European journal of nuclear medicine and molecular imaging · 2025
    Article
  7. Review
  8. Clinical development of allogeneic chimeric antigen receptor αβ-T cells.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  9. Perspective of usingFrontiers in immunology · 2025
    Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. FDA Approval Summary: Axicabtagene Ciloleucel for Second-Line Treatment of Large B-Cell Lymphoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  15. Article
  16. Article
  17. Review
  18. 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

10 authors at 2 institutions in 1 country.

Najat BouchkoujCenter for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-3357-6941
Megan ZimmermanCenter for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Yvette L KasamonCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Cong WangCenter for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Tianjiao DaiCenter for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Zhenzhen XuCenter for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Xiaofei WangCenter for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Marc TheoretCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Tejashri Purohit-ShethCenter for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Bindu GeorgeCenter for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Center for Biologics Evaluation and Research · USUnited States Food and Drug Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In March 2021, the U.S. Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after at least 2 lines of systemic therapy. Approval was based on ZUMA-5, a single-arm, open-label, multicenter trial that evaluated a single infusion of axicabtagene ciloleucel, preceded by lymphodepleting chemotherapy with cyclophosphamide and fludarabine, in this population. Efficacy was based on objective response rate (ORR) and duration of response (DOR) as determined by an independent review committee. Among 81 patients in the primary efficacy analysis, having a median of 3 (range 2-9) prior lines of systemic therapy, the ORR was 91% (95% confidence interval [CI]: 83-96) with a complete remission (CR) rate of 60% and a median time-to-response of 1 month. The median DOR was not reached, and the 1-year rate of continued remission was 76% (95% CI: 64-85). For all leukapheresed patients with FL in this trial (n = 123), the ORR was 89% (95% CI: 83-94) with a CR rate of 62%. Among 146 patients with indolent lymphoma evaluated for safety, cytokine release syndrome occurred in 84% (Grade ≥3, 8%) and neurological toxicities occurred in 77% (Grade ≥3, 21%), leading to implementation of a risk evaluation and mitigation strategy. Serious adverse reactions occurred in 48%. Post-marketing studies will further evaluate clinical benefit in patients with r/r FL and long-term safety.

Indexed as

Biological ProductsLymphoma, FollicularLymphoma, Large B-Cell, DiffuseAdultAntigens, CD19HumansImmunotherapy, AdoptiveAntigens, CD19axicabtagene ciloleucelBiological Productsaxicabtagene ciloleucelfollicular lymphomaindolent non-Hodgkin lymphoma

Identifiers

PMID35403693
PMCPMC9255972
OpenAlexW4214613217

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.