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# FDA Reviewers Question Amgen’s Lumakras Study
- URL: https://www.fdaweb.com/fda-reviewers-question-amgens-lumakras-study/
- Published: 2023-10-03T12:00:00.000Z
- Updated: 2026-09-14T19:00:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155473

FDA medical reviewers are questioning the validity of the CodeBreak 200 post-marketing study of Amgen’s Lumakras (sotorasib) that is the basis of the company’s request to have the drug’s 5/28/21 accelerated approval converted to a full approval. A briefing document distributed in advance of the 10/5 meeting of the FDA Oncologic Drugs Advisory Committee [says](https://www.fda.gov/media/172696/download?ref=fdaweb.com) Lumakras is an oral targeted therapy to treat patients with KRAS G12C-mutated non-small cell lung cancer.

The committee is not being asked whether CodeBreak 200 should serve as a basis for conversion of the drug’s approval, FDA says. Rather, the committee is to discuss whether the results of CodeBreak 200 can be reliably interpreted and whether it can be considered an adequate and well-controlled trial.

The briefing document says medical reviewers noted the median progression-free survival benefit of about five weeks was less than the standard imaging interval of six weeks. The reviewers also reportedly looked at multiple sources of potential systemic bias in the trial: **(1)** asymmetric early dropout, with greater dropout on the docetaxel control arm; **(2)** investigator assessments of progressive disease favoring the sotorasib arm; and **(3)** crossover of patients from docetaxel to sotorasib before assessment of disease progression by BICR (blinded independent central review).

The reviewers conclude that the trial results are confounded by multiple sources of systemic bias, raising concerns about whether CodeBreak 200 can be considered an adequate and well-controlled trial.