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FDA Grants Fast Track Designation to AMG 510 for KRAS G12C+ NSCLC

Lisa Astor
Published: Monday, Sep 09, 2019

The FDA has granted a fast track designation to the investigational KRAS inhibitor AMG 510 for the treatment of patients with KRAS G12C–mutated non–small cell lung cancer (NSCLC) who have received prior treatment.1

Additional findings from the phase I study will also be presented at the 2019 ESMO Congress.


  1. Amgen announces new clinical data evaluating novel investigational KRASG12C inhibitor in larger patient group at WCLC 2019 [news release]. Thousand Oaks, CA: Amgen; September 8, 2019. Accessed September 9, 2019.
  2. Govindan R, Fakih M, Price T, et al. Phase 1 study of safety, tolerability, PK and efficacy of AMG 510, a novel KRASG12C inhibitor, evaluated in NSCLC. Presented at: IASLC 20th World Conference on Lung Cancer; September 7-10, 2019; Barcelona, Spain. Abstract OA02.02.

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