Sotorasib’s Accelerated Approval

This Viewpoint reviews the accelerated approval process and lack of postapproval studies to verify its benefit as it applied to sotorasib, a treatment for non–small cell lung cancer with the KRAS g12c mutation, and recommends measures to ensure confirmatory follow-up studies.

Authors

Institutions

Publication Details

Journal
JAMA Oncology
Published
2025-03-13
DOI
https://doi.org/10.1001/jamaoncol.2025.0039
Citations
3
Primary Topic
Lung Cancer Treatments and Mutations
Type
article
Field-Weighted Citation Impact
4.56
Controls
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article

Sotorasib’s Accelerated Approval

Aaron Seth Kesselheim, Mark J. Ratain
3 citations
JAMA Oncology
Lung Cancer Treatments and Mutations
4.56
article

Sotorasib’s Accelerated Approval

Aaron Seth Kesselheim, Mark J. Ratain
article en
3 citations

Abstract

This Viewpoint reviews the accelerated approval process and lack of postapproval studies to verify its benefit as it applied to sotorasib, a treatment for non–small cell lung cancer with the KRAS g12c mutation, and recommends measures to ensure confirmatory follow-up studies.

JAMA OncologyVol. 11(5)
Brigham and Women's Hospital (US), Harvard University (US), University of Chicago (US)
Good health and well-being
Openalex Percentile: Top 6%
Lung Cancer Treatments and Mutations
4.56
DOISourceOpenAlex
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