Amgen posts sotorasib trial results, updates Neupogen and Repatha labels; ITP trial recruits

Amgen's week included one trial results posting, two FDA-approved labeling supplements, and one newly recruiting Phase 3 study.

• Amgen posted results for CodeBreaK 201, a Phase 2, multicenter, open-label study of sotorasib (AMG 510) in subjects with Stage IV NSCLC whose tumors harbor a KRAS G12C mutation in need of first-line treatment.¹ The trial was terminated for futility, with an actual start date of 2022-01-28 and actual primary completion on 2025-05-28¹, and enrollment reached 42 participants.¹
• The FDA approved a labeling supplement for NEUPOGEN (BLA103353) SUPPL 5202, sponsored by Amgen, with submission status AP (approved) and a status date of 2026-07-16, and a label dated 2026-07-21.²
• The FDA approved a labeling supplement for REPATHA (BLA125522) SUPPL 49, sponsored by Amgen Inc, with submission status AP (approved) and a status date of 2026-07-15, and a label dated 2026-07-15.³
• Amgen's ROMISTER study is now recruiting: a Phase 3, randomized, multicenter, open-label study to evaluate the efficacy and safety of romiplostim plus predniso(lo)ne vs. predniso(lo)ne alone for the treatment of adults with previously untreated Primary Immune Thrombocytopenia (ITP).⁴ The trial has an estimated enrollment of 126 participants⁴, with its primary outcome being the percentage of participants with a durable platelet response (DPR) at 8 weeks.⁴