2025 FDA-AACR Workshop: Approach to Novel Oncology Endpoint Development

U.S. FDA Oncology Center of Excellence and the American Association for Cancer Research (AACR), will host a one-day hybrid workshop on September 11, 2025, at the Hilton Alexandria Old Town. 2025 FDA-AACR Workshop will address the challenges and opportunities in using novel clinical trial endpoints that can inform regulatory decisions, especially in early-stage and rare cancers where overall survival measurement may be impractical.

Key topics include past successes in endpoint development, evidence requirements to validate novel endpoints, balancing risks and benefits, and leveraging these endpoints within accelerated approval pathways. The workshop will feature case studies and discussions led by experts from regulatory agencies, academia, industry, and patient advocacy.