Something’s off.
This look at claims data from three major Swiss oncology centers reveals requests for off-label drug approval are made for one in five patients (n=3046), the majority for first- (45%) or second- (31%) line treatment. Approval was granted for roughly two-thirds of requests with randomized trials to back them up...just like for two-thirds of requests without such evidence. Bottom line is, with increasing molecular indications of drug sensitivities coupled with FDA approval lagtimes of several months or more, off-label requests for oncologic therapies are only going to increase leaving us in serious need of transparent, efficient, and equitable approval processes. | Herbrand, JAMA Netw Open 2021
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