Know the questions a skeptical FDA reviewer will probe — before you're in the room.
In July 2023, the FDA granted full approval to lecanemab (Leqembi) for early Alzheimer's disease — the first therapy to demonstrate disease-modifying benefit at that level of evidence. Fourteen months later, the National Institute for Health and Care Excellence (NICE) declined to recommend it for the NHS. A third
ComboMATCH is described as having opened with multiple treatment trials and more in development. The design paper lists the scientific rationale, the biomarker-matching infrastructure, and the cooperative group coordination. Press releases count the substudies that activated. The ECOG-ACRIN treatment trials page lists the ones currently open or closed to accrual.
The disagreements in the comment docket tell you where Bayesian regulatory science still hasn't settled.
