ARTICLE | Regulation

Pazdur rings bell for dose optimization, wants to modernize clinical tox 

FDA oncology chief tells sponsors to move beyond the era of MTD, says patients define tolerability: a conversation at ASCO22 

June 7, 2022 6:13 PM UTC

Richard Pazdur wants to pull sponsors of cancer therapies out of their entrenched focus on achieving the highest possible response rate at all costs, and shift their thinking to incorporate toxicity as a key parameter in defining an optimal dose.

Speaking at an ASCO session moderated by BioCentury, the FDA Oncology Center of Excellence director, along with deputy directors Paul Kluetz and Marc Theoret, repeatedly underscored that FDA will be requiring drug developers to address toxicity early in clinical development and to present accurate tolerability data, with the patient voice a key component in the definition of what is tolerable...

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