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. 2025 May 1;11(5):479-480.
doi: 10.1001/jamaoncol.2025.0039.

Sotorasib's Accelerated Approval: Wrong Dose and Indication

Mark J Ratain  1 , Aaron S Kesselheim  2
Affiliations

Sotorasib's Accelerated Approval: Wrong Dose and Indication

Mark J Ratain et al. JAMA Oncol. .
No abstract available

Plain language summary

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 KRASg12c mutation, and recommends measures to ensure confirmatory follow-up studies.

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