FDA to Require Cancer Drugmakers to Probe ‘Unnecessary Toxicity’

June 9, 2021, 7:06 PM

Drug companies must do more front-end work to pinpoint the right dose for their cancer drugs before moving to the pivotal studies used to approve those therapies, the FDA’s cancer chief said.

“We are going to start making it more of a requirement to look at this,” Richard Pazdur, director of the Oncology Center of Excellence at the Food and Drug Administration, said Wednesday. “Unless we address this issue, we’re going to get into a very difficult situation of not knowing what’s the correct dosage, subjecting people to unnecessary toxicity with very little benefit.”

The FDA wants to shift drugmakers ...

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