Sotorasib’s Accelerated Approval: Wrong Dose and Indication

The atuhors critique the FDA’s accelerated approval of sotorasib for non-small cell lung cancer, highlighting issues with the approved dose and indication. Confirmatory trials revealed no clear benefit of the higher dose over a lower dose, and reforms should be made to ensure drug labels reflect accurate dosing information. CMS should also consider covering lower doses if clinical trials show them to be equally effective.