Gilberto Lopes, Professor and Chief of the Division of Medical Oncology at Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, shared on LinkedIn:
“A busy day for multicancer early detection.
Yesterday, the NHS-Galleri randomized trial was published in the New England Journal of Medicine. Today, an FDA advisory committee voted in favor of Galleri’s overall benefit-risk profile. And today my piece in the Wall Street Journal appeared alongside our new medRxiv preprint.
The most important point is that none of these results deserves a simplistic interpretation.
The NHS-Galleri trial missed its primary endpoint: screening did not significantly reduce the combined incidence of stage III and IV cancers across the 12 prespecified cancer types. The incidence-rate ratio was 1.03, with P=0.63.
But stage IV cancer – a key secondary endpoint – was lower in the screened group, with an incidence-rate ratio of 0.86.
That distinction matters clinically.
Stage III and stage IV are not interchangeable outcomes. Preventing metastatic disease may still matter even when a cancer is diagnosed at stage III.
In our modeling work, using the randomized cancer-specific stage IV differences and English stage-specific survival, we estimated approximately 466 potential life-years gained annually per million people screened, conditional on the observed stage IV reduction representing true downstaging.
That is not proof of a mortality benefit.
It is a way of asking a different question: if the randomized stage shift is real and durable, what might its clinical consequence be?
Today’s FDA advisory panel reflected that uncertainty rather well.
The panel voted:
- 10–0 that Galleri is reasonably safe
- 6–4 that there is reasonable assurance of effectiveness
- 7–2, with one abstention, that the benefits outweigh the risks
The FDA is not bound by those votes.
That split on effectiveness is important. So are the unresolved questions:
- Will stage IV reductions translate into fewer cancer deaths?
- What are the consequences of false positives and diagnostic workups?
- Who should be screened?
- How should cost and access be handled?
- And how should MCED testing complement – rather than replace – established cancer screening?
My view is not that these questions have been settled. They have not.
My view is that uncertainty cuts both ways.
A negative composite endpoint should not make us ignore a potentially meaningful randomized stage IV signal. But a favorable secondary endpoint should not be treated as proof of mortality benefit either.
If regulators ultimately judge the evidence sufficient for access, I think informed patients and their physicians should be able to examine the benefits, uncertainties, risks, and costs together and decide whether testing makes sense for that individual.
Approval need not mean universal screening.
You can also read: Gilberto Lopes Named Candidate for UICC President-elect 2026–2028
