US FDA’s ‘Project Optimus’ Will Encourage Move Away From Conventional Dose-Finding For Modern Cancer Therapies

Simply carrying forward the maximum tolerated dose into later-stage trials does not account for the importance of long-term tolerability – and the fact that higher doses are not necessarily better for patients.

"Optimus Prime" sits in the staging area during Transformers 3 filming on Wacker Drive in Chicago, Illinois on AUG 01, 2010. (Photo By Raymond Boyd/Michael Ochs Archives/Getty Images)
FDA's prepares to take the wheel and transform oncology dosing. • Source: Raymond Boyd/Michael Ochs Archives/Getty Images

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