Confirmatory study delay after FDA accelerated approval should be ‘cautionary sign’
April 25, 2025
In a Healio/HemOnc Today article about a study that found cancer drugs receiving accelerated approval from the FDA gained regular approval significantly faster if their confirmatory trials demonstrated meaningful clinical benefits cites a separate study led by Catherine Hwang, M.D., that evaluated four cancer drug indications that initially received accelerated approval but eventually had to be withdrawn.