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US FDA Plans To Get Tougher On Oncology Dose Optimization

 
• By Sarah Karlin-Smith

FDA’s Rick Pazdur notes that while the agency recently allowed Amgen to conduct a key dose comparison study for its landmark KRAS inhibitor post-market it will be less willing to do this in the future, particularly in settings that are less refractory.

Richard Pazdur
FDA’s Pazdur says cancer programs may soon be required to do more dose finding

The US Food and Drug Administration is likely to require more dose-finding studies for oncology drugs, particularly in less refractory settings, Oncology Center of Excellence Director Rick Pazdur said.

“We are going to start making it more of a requirement to look at this quite closely,” Pazdur said on 9 June at a Stat News ASCO recap event

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