Abstract
Sotorasib (LUMAKRAS™) is a RAS GTPase family inhibitor being developed by Amgen for the treatment of solid tumours with KRAS mutations, including non-small cell lung cancer (NSCLC) and colorectal cancer. In May 2021, sotorasib was granted accelerated approval by the US FDA for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. This article summarizes the milestones in the development of sotorasib leading to this first approval for KRAS G12C-mutated NSCLC.
© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
MeSH terms
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Antineoplastic Agents / adverse effects
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Antineoplastic Agents / pharmacokinetics
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Antineoplastic Agents / pharmacology*
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Antineoplastic Agents / therapeutic use*
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Carcinoma, Non-Small-Cell Lung / drug therapy*
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Carcinoma, Non-Small-Cell Lung / pathology
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Clinical Trials as Topic
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Drug Approval
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Humans
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Lung Neoplasms / drug therapy*
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Lung Neoplasms / pathology
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Piperazines / adverse effects
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Piperazines / pharmacokinetics
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Piperazines / pharmacology*
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Piperazines / therapeutic use*
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Pyridines / adverse effects
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Pyridines / pharmacokinetics
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Pyridines / pharmacology*
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Pyridines / therapeutic use*
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Pyrimidines / adverse effects
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Pyrimidines / pharmacokinetics
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Pyrimidines / pharmacology*
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Pyrimidines / therapeutic use*
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United States
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United States Food and Drug Administration
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ras Proteins / antagonists & inhibitors
Substances
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Antineoplastic Agents
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Piperazines
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Pyridines
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Pyrimidines
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sotorasib
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ras Proteins