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# Amgen NDA Gets Priority Review for Lung Cancer
- URL: https://www.fdaweb.com/amgen-nda-gets-priority-review-for-lung-cancer-2/
- Published: 2021-02-17T12:00:00.000Z
- Updated: 2026-09-14T16:47:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148681

FDA has accepted for priority review an Amgen NDA for sotorasib for treating patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy. The submission is based on data from the Phase 2 CodeBreaK 100 clinical trial that studied patients with locally advanced or metastatic NSCLC whose cancer had progressed despite treatment with chemotherapy and/or immunotherapy. The primary endpoint was centrally assessed objective response rate. The agency has set an 8/16 user fee review action target date.