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On February 17, Amgen announced that the US FDA has granted the company's KRAS G12C inhibitor sotorasib priority review for the treatment of locally advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutations.
NSCLC accounts for 80%-85% of all lung cancers, and most patients (66%) have advanced or metastatic disease at the time of initial diagnosis.
Sotorasib developed by Amgen is the first KRAS G12C inhibitor to enter the clinical development stage.
This New Drug Application (NDA) is based on the results of a Phase 2 clinical trial called CodeBreaK 100.
This application is currently under review under the FDA's Real-time Oncology Review (RTOR) pilot program.
Note: This article is intended to introduce medical and health research, not a treatment plan recommendation.
Reference materials:
[1] FDA Grants Sotorasib Priority Review Designation For The Treatment Of Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer.
