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.
Immuno-Oncology Add-On Trials: More May Not Be Better, US FDA Cautions
Oncology developers should ensure clinical development plans involving early-stage trials adding on to perioperative treatment regimens will show that new therapies are adding benefit in each phase, Oncology Center of Excellence Director Richard Pazdur said.
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