Oncology sponsors developing new add-on treatments in early-stage cancer settings should prepare for the US Food and Drug Administration to push them to design trials that can clearly demonstrate efficacy in each phase of treatment, i.e. neoadjuvant and adjuvant.
Key Takeaways
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FDA is increasingly uncomfortable with the quality of evidence that has made checkpoint inhibitors the accepted treatment in both the neoadjuvant and adjuvant settings.
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The most “palatable” option for FDA appears to be a three-arm trial design where one group gets placebo for the full regimen, one group gets the investigational agent for the full regimen, and the third group switches from treatment to placebo after surgery
Oncology Center of Excellence Director Richard Pazdur delivered that message in closing remarks after a 9 May discussion of trial designs for perioperative cancer treatments co-hosted by the FDA and the American Association for Cancer Research
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