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Article

FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC.

Clinical cancer research : an official journal of the American Association for Cancer Research - 14 Apr 2022

Nakajima Erica C, Drezner Nicole, Li Xiaoxue, Mishra-Kalyani Pallavi S, Liu Yajun, Zhao Hong, Bi Youwei, Liu Jiang, Rahman Atiqur, Wearne Emily, Ojofeitimi Idara, Hotaki Lauren Tesh, Spillman Dianne, Pazdur Richard, Beaver Julia A, Singh Harpreet

Abstract excerpt

On May 28, 2021, the FDA granted accelerated approval to sotorasib (Lumakras, Amgen) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a Kirsten rat sarcoma proto-oncogene (KRAS) G12C mutation who have received at least one prior systemic therapy. The approval was based on CodeBreaK 100 (Study 20170543), a dose-escalation and dose-expansion trial in patients with an advanced, KRAS...

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Identifiers

PMID: 34903582
DOI: 10.1158/1078-0432.CCR-21-3074
PMCID: PMC9012672

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PubMed metadata and Literature Corpus relationships. Corpus snapshot updated 7 Sept 2026. Manifest publication-graph-cohort-2026-09-07.1.

Source receipt: pubmed, retrieved 7 Sept 2026.

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