FDA Oncology Chief Emphasizes Equitable Standards in Confirmatory Trial Rejections at AACR24

1. At the inaugural American Association for Cancer Research (AACR) Oncology Industry Partnering Event in 2024, Dr. Richard Pazdur, the FDA's oncology chief, addressed various topics, including confirmatory trial requirements.
2. Dr. Pazdur emphasized the importance of maintaining a "level playing field" in the context of confirmatory trial rejections.
3. The FDA's Oncology Center of Excellence (OCE), led by Dr. Pazdur, granted 83 therapeutic approvals in 2023, including 14 for new drugs.
4. The FDA encourages biopharma companies to discuss simplified trial designs with the agency under Project, which is likely a collaborative initiative aimed at improving trial efficiency.
5. Dr. Pazdur's statements, characterized as sometimes blunt and humorous but also strategically vague, offer guidance to the OCE's practice and priorities.
6. The FDA's oncology chief has adopted a "regulatory flexibility" approach when it comes to confirmatory trials.