Evidence map›Paper›PMID 35679021›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022

FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer.

Elizabeth S Duke, Amy K Barone, Somak Chatterjee, Pallavi S Mishra-Kalyani, Yuan-Li Shen, Emasenyie Isikwei, Hong Zhao, Youwei Bi, Jiang Liu, Nam Atiqur Rahman and 9 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03690388 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
6.0field-weighted citation impact, top 3% 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.

NCT03690388 phase3active not recruitingnot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects With Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

TypeinterventionalSponsorExelixisRan2018 to 2026Enrolled187ConditionsDifferentiated Thyroid CancerArmsCabozantinib, Placebo
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. One Step Ahead: Preventing Tumor Adaptation to Immune Therapy.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2025
    Review
  10. Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. The MET Oncogene: An Update on Targeting Strategies.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  17. TiDrug delivery and translational research · 2024
    Review
  18. Article
  19. MET Oncogene Targeting for Cancer Immunotherapy.International journal of molecular sciences · 2024
    Review
  20. Review
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

19 authors at 2 institutions in 1 country.

Elizabeth S DukeCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.ORCID 0000-0002-3361-1436
Amy K BaroneCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Somak ChatterjeeCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Pallavi S Mishra-KalyaniCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Yuan-Li ShenCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Emasenyie IsikweiCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Hong ZhaoCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Youwei BiCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Jiang LiuCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Nam Atiqur RahmanCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Emily WearneCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
John K LeightonCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Maritsa StephensonCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Idara OjofeitimiCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Barbara ScepuraCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Abhilasha NairCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Richard PazdurCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Julia A BeaverCenter for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Harpreet SinghCenter for Drug Evaluation and Research, 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 September 17, 2021, the FDA approved cabozantinib (Cabometyx; Exelixis, Inc.) for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine (RAI)-refractory or ineligible. This is the first approval for patients with RAI-refractory locally advanced or metastatic DTC who have progressed following prior therapy and the first approval in pediatric patients with DTC. The approval was based on data from COSMIC-311 (Study XL184-311, NCT03690388), an international, randomized, double-blind trial in which patients with locally advanced or metastatic RAI-refractory DTC that progressed during or following treatment with at least one VEGFR-targeting tyrosine kinase inhibitor were treated with either cabozantinib 60 mg orally once daily (N = 170) or placebo with best supportive care (N = 88). The primary efficacy outcome measures were progression-free survival (PFS) and overall response rate (ORR) by blinded independent central review per RECIST 1.1. The median PFS was 11.0 months [95% confidence interval (CI), 7.4-13.8] in the cabozantinib arm compared with 1.9 months (95% CI, 1.9-3.7) in the control arm, with an HR of 0.22 (95% CI, 0.15-0.31). The endpoint of ORR was not met. No new safety signals were identified with the exception of hypocalcemia, which was added as a warning in the product labeling.

Indexed as

AdenocarcinomaAnilidesPyridinesThyroid NeoplasmsAdultAngiogenesis InhibitorsChildHumansIodine RadioisotopesProtein Kinase InhibitorsAngiogenesis InhibitorsAnilidescabozantinibIodine RadioisotopesProtein Kinase InhibitorsPyridines

Identifiers

PMID35679021
PMCPMC9529996
OpenAlexW4282912879

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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 Socratic graph.