FDA Finalizes Guidance to Broaden Cancer Trial Eligibility

By Jennifer KulpaThe FDA has finalized three guidance documents urging sponsors to ease overly restrictive eligibility criteria in cancer clinical trials. The recommendations address performance status, washout periods and concomitant medications, and laboratory values, potentially expanding enrollment to more patients treated in ambulatory settings.Issued in July 2026 by the FDA’s Oncology Center of Excellence, Center for Drug Evaluation and Research, and Center for Biologics Evaluation a