Policy & Advocacy

FDA Engagement

SITC leadership continued to prioritize meaningful engagement with the U.S. Food and Drug Administration (FDA), recognizing the agency’s critical role in ensuring that novel cancer immunotherapies reach patients safely and efficiently. Throughout 2025, SITC identified priority areas where dialogue with the FDA could meaningfully advance the safe, effective, and timely development of emerging IO therapies. Key areas of focus included continued discussions around release criteria and the development of surrogate clinical trial endpoints.

SITC further advanced its commitment to regulatory science through multiple meetings. The Society partnered with the FDA and the American Association for Cancer Research (AACR) to host a workshop on novel oncology endpoints, fostering shared understanding of scientific and regulatory challenges. In addition, SITC also convened its annual Regulatory Roundtable at the SITC Annual Meeting, providing a forum for open dialogue among regulators, researchers and industry leaders.

Collectively, these efforts reflect SITC’s ongoing commitment to regulatory clarity, scientific advancement, and strong collaboration with the FDA.

Congressional Advocacy and Federal Funding

SITC continued to inform policymakers about the critical importance of sustained, predictable federal funding for cancer research and the direct impact of federal actions on the immunotherapy ecosystem. In 2025, SITC organized two Capitol Hill Days, one in the spring and in the fall.

The spring Hill Day continued SITC's annual engagement in the appropriations process, advocating for research funding and specific legislative language federal spending bills. The fall Hill Day, a new day of advocacy, leveraged the presence of SITC volunteers traveling to Washington DC for the annual meeting and expanded engagement with new advocates and congressional offices. Across both efforts, volunteers participated in more than 45 meetings with congressional offices, sharing advances in cancer immunotherapy, underscoring the urgency of research funding and educating staff on how federal decisions impact scientific progress.

Building on this momentum, SITC launched a comprehensive Advocacy Toolkit, available on the SITC website. This resource provides members with clear guidance, practical tools, and educational materials to support advocacy efforts and sustain a strong immunotherapy voice on Capitol Hill.

Comment Letters and Public Statements

Comment letters and public statements remain a key mechanism for SITC to provide direct, timely input to policymakers on issues impacting the immunotherapy field. Drafted by the SITC Policy Committee and relevant expert committees, and reviewed by the Executive Committee and/or Board of Directors, these communications ensure alignment with SITC’s strategic priorities.

In 2025, SITC authored or signed on to ten letters and statements addressing major policy issues, including federal agency staffing changes, research funding levels, and and regulatory and administrative actions affecting biomedical research. These efforts included statements recognizing retiring FDA leaders; responses to staffing reductions across HHS, NCI, and FDA; advocacy related to indirect cost rate reductions; funding and structural concerns at NIH; and collaborative letters with organizations such as One Voice Against Cancer, Research!America, and disease-focused advocacy groups. Together, these actions reinforced SITC’s role as a trusted, science-driven voice in federal policy discussions.

Quality and Care Delivery

SITC remains committed to improving quality of care for patients receiving immunotherapy while ensuring providers have the tools and support necessary to deliver exceptional care. Led by the Quality Subcommittee and Policy Committee, SITC members have developed immunotherapy-specific quality measures designed for inclusion in federal programs and registries. These quality measures aim to ensure appropriate patient care, support reimbursement processes, and gather data to assess and improve care over time. Currently, SITC has two fully developed and tested quality measures, both of which have achieved significant milestones:

• Both measures are included in the Centers for Medicare & Medicaid Services (CMS) Merit-based Incentive Payment System (MIPS) Quality Payment Program and the Oncology Measure Value Pathway

Inclusion in CMS programs allows providers to use these measures to support reimbursement while delivering high-quality immunotherapy care. Current SITC Quality Measures include:

• Appropriate Intervention for Immune-Related Diarrhea and/or Colitis in Patients Treated with Immune Checkpoint Inhibitors
• Positive PD-L1 Biomarker Expression Test Result Prior to First-Line Immune Checkpoint Inhibitor Therapy