Early endpoints have the potential to get effective drugs to patients faster, but granting approval to drugs—even accelerated approval—comes with the risk that ineffective or even harmful drugs will be given to patients.
“If we don't have these intermediate endpoints to get new drugs to patients, we'd have to wait… I think somebody mentioned in one of the conversations I had while I was reporting on this, that the readout would be upwards of 17 years to get information about these new drugs that are being developed if we rely on PFS, overall survival, the sort of traditional clinical endpoints,” Jacqurelyn Cobb, associate editor of The Cancer Letter, said, “So, that's sort of the general push, to make it so effective drugs, can get it to patients faster. Now, with that, of course, comes a lot of risks. And that's the balance, the conversation. That's why this is something that's so fun to cover.”
In this episode of In the Headlines, Jacquelyn and Paul Goldberg, editor and publisher of The Cancer Letter, talk about Friends of Cancer Research's ctMoniTR project, a large-scale effort that aims to improve the efficiency of the development of intermediate endpoints.
The ctMoniTR project aims to learn and improve upon previous development of early endpoints, such as minimal residual disease, which is now an accepted early endpoint for the accelerated approval multiple myeloma.
Jacquelyn and Paul also talk through Paul’s story about the new director of the National Institute of Environmental Health Sciences, and Jacquelyn’s story about the recent results from GRAIL’s PATHFINDER 2 study, which is intended to support an FDA premarket approval application.
Stories mentioned in this podcast include:
Duke brain cancer researcher Kyle Walsh named director of NIEHS
GRAIL to use new study results to seek FDA approval of Galleri MCD test
Experts warn that loss of carcinogen surveillance threatens to increase cancer incidence
A transcript of this podcast is available: https://cancerletter.com/podcastc/20251029-ctdna/