High-dose paradigm for anti-cancer drugs under scrutiny
December 17, 2022
US Food and Drug administration is investigating ways of having lower doses of chemotherapy approved for anti-cancer chemotherapy drugs.
Current approach in clinical trials for chemotherapy drug approval is to use an increasing concentration of the drug until 1/3 of the clinical trial participants abandon the clinical trial. Then, in general, a drug concentration just below this threshold is selected for enroling additional participants.
"This ‘maximum tolerated dose’ approach is now being challenged in the United States. Officials at the Oncology Center of Excellence (OCE), part of the US Food and Drug Administration (FDA), are becoming concerned that the side effects of some cancer drugs are so toxic that patients stop taking them, writing in a 2021 New England Journal of Medicine editorial1 that sometimes “less is more”. "
by Marcus A. Banks / Nature / December 14, 2022
Read more here: Challenging the high-dose paradigm for cancer drugs