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# Panel Votes Down Amgen’s Confirmatory Study
- URL: https://www.fdaweb.com/panel-votes-down-amgens-confirmatory-study/
- Published: 2023-10-05T12:00:00.000Z
- Updated: 2026-09-14T19:01:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155503

FDA’s Oncologic Drugs Advisory Committee 10/5 voted 10 to 2 that the CodeBreak 200 confirmatory study, with its progression-free survival primary endpoint, cannot be reliably interpreted as the basis for Amgen’s request to have Lumakras’s (sotorasib) 5/28/21 accelerated approval converted to a full approval. Lumakras is an oral targeted therapy to treat patients with KRAS G12C-mutated non-small cell lung cancer.

Panel members echoed concerns raised in an FDA [briefing document](https://www.fda.gov/media/172696/download?ref=fdaweb.com) released before the panel met. In it, medical reviewers noted that the median progression-free survival benefit of about five weeks was less than the standard imaging interval of six weeks. The reviewers also 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 concluded 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.