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

 
• By Kate Rawson

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

The Oncology Center of Excellence’s latest “project” under development will investigate strategies for better dose optimization of oncology products and how to best implement them, US Food & Drug Administration Office of Oncologic Diseases medical oncologist Mirat Shah said during a “hot topics” in cancer regulation panel discussion at the American Association for Cancer Research annual meeting on 20 May.

While Shah did not give any specifics on “Project Optimus” itself, promising “there will be more to come,” she did outline what a better dose optimization program would look like

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