Costs and benefits of early access to new cancer drugs through the US Food and Drug Administration’s accelerated approval pathway: retrospective observational study and economic evaluation
Huseyin Naci, Mahnum Shahzad, Peter Murphy, Yichen Zhang, Rebecca Costa, Joseph S Ross, Anita K Wagner · 2025
Read Costs and benefits of early access to new cancer drugs through the US Food and Drug Administration’s accelerated approval pathway: retrospective observational study and economic evaluation by Huseyin Naci, Mahnum Shahzad, Peter Murphy, Yichen Zhang, Rebecca Costa, Joseph S Ross, Anita K Wagner (2025) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-12718571.txt.
Description
Huseyin Naci and six co-authors weigh the costs and gains of fast-tracked cancer drugs in this two thousand twenty-five study. The US Food and Drug Administration can approve drugs early on promising early data. Full proof of benefit comes later, in confirmatory trials. The team asked what early access buys Medicare patients, in life gained and in extra spending. They studied drug uses that won accelerated approval over about a decade.
They followed patients from first approval until regular approval, withdrawal, or the end of two thousand twenty. Survival gains were set against the added Medicare costs of earlier use. The study is a cost-benefit check on a pathway meant to help patients fast. Its findings inform debate on how much early evidence should be enough.
Catalog record
| CREATOR | Huseyin Naci, Mahnum Shahzad, Peter Murphy, Yichen Zhang, Rebecca Costa, Joseph S Ross, Anita K Wagner |
|---|---|
| YEAR | 2025 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 60 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |