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Sotorasib: First Approval

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posted on 2021-07-29, 22:00 authored by Hannah A. Blair
Funding The preparation of this review was not supported by any external funding.
Authorship and Conflict of interest During the peer review process, the manufacturer of the agent under review was offered an
opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific
completeness and accuracy. Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts
of interest. All authors contributed to the review and are responsible for the article content.
Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not

Additional information about this Adis Drug Review can be found here.

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.

© Springer Nature Switzerland AG 2021.


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