Coming October 2: SITC releases abstract titles with each presenting author’s institution (nearly 1,300 last year). We’ll add them to this guide once they’re out.

U.S. Food and Drug Administration at SITC 2026

Nov 4–8, 2026 Phoenix, AZ ~6k attendees Website

U.S. Food and Drug Administration brings 1 presentation to SITC 2026 in Phoenix. Its program focuses on the regulatory framework for new immuno-oncology agents and on current hot topics in oncology regulation. The most concrete topic is the regulatory view of shifting immunotherapy safety assessment from conventional methods to new approach methodologies.

Organization

SITC 2026 Attendance

U.S. Food and Drug Administration

Silver Spring, MD

Government & non-profit

U.S. federal agency that regulates drugs, biologics and medical devices, including cancer immunotherapies.

Session

Wed Nov 4
2:10pm–2:55pm

Panel Discussion 1: Conversations with FDA Oncology Leaders on Hot Topics

Regulatory

Session

Wed Nov 4
3:10pm–3:55pm

Panel Discussion 2: Biomarker Discovery and Digital AI

Biomarkers · AI & data

Session

Wed Nov 4
4:10pm–4:55pm

Panel Discussion 3: Regulatory Framework for New IO Agents

Regulatory · New agents

Talk

Fri Nov 6
2:45pm–3:00pm

Part of Session 106b: Human Ex Vivo Models for Immunotherapy Testing: From Tumor Explants to Tumor-on-Chip

From Conventional to New Approach Methodologies: Regulatory Considerations for Immuno-Oncology Safety Assessment

Regulatory · Models & tech

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