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Sotorasib: First Approval.


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.

SUBMITTER: Blair HA 

PROVIDER: S-EPMC8531079 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Sotorasib: First Approval.

Blair Hannah A HA  

Drugs 20210901 13


Sotorasib (LUMAKRAS<sup>™</sup>) 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  ...[more]

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