Policy & Advocacy

FDA Engagement

In 2023, SITC leadership strengthened its close engagement with the U.S. Food and Drug Administration (FDA). In addition to having direct liaisons with the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), SITC leadership carefully and thoughtfully identified vital areas of dialogue with the FDA that will support safe, efficacious, and expeditious novel therapies. Key initiatives with the FDA include discussions on surrogate endpoints and revaluation of release criteria for cellular therapies.

SITC previously convened cellular therapy experts from academia, government, and industry to identify significant regulatory hurdles facing cellular therapies related to the Investigational New Drug Application (IND) process. The group identified release criteria specifications as the most significant hurdle to address. As such, in December 2023, SITC convened a new group of cellular therapy experts to dive deeper into release criteria and provide recommendations to the field on their application, usefulness, and role in the regulatory process. Discussions with the FDA will be ongoing through 2024.

In addition, SITC leadership emphasized the discovery of effective novel surrogate endpoints is critical to increasing the quality, quantity and speed at which novel therapies can gain accelerated approval through clinical trials. As such, SITC has convened a task force to hold a summit on this topic in April of 2024.

Advocating for Increased Funding for Immunotherapy Research

In March 2023, SITC volunteers advocated for annual appropriation bills to include immunotherapy-specific report language. Setting a society record, SITC volunteers visited over 25 congressional offices to inform staffers of the importance of the language directed at the FDA and the National Cancer Institute/National Institutes of Health (NCI/NIH). SITC’s 2023 language focused on the ongoing “Crisis in Clinical Research” initiative and requested each agency to address critical aspects of clinical trial operations and efficiency. The language directed at the NCI focused on assisting workforce development and training to alleviate the skilled labor shortage contributing to the crisis. The language directed at the FDA focused on asking for further guidance in defining the critical data elements needed for clinical trials to reduce over-burdensome data collection. While FY2024 budgeting has not concluded, SITC’s language is included in preliminary versions of draft appropriations bills.

SITC Quality Measures Project

SITC is focusing on developing immunotherapy-centric quality measures to be included for submission to the Merit-Based Incentive Payment System (MIPS) coordinated by the Centers for Medicare and Medicaid Services (CMS). Through this effort, SITC aims to ensure that cancer patients across the United States will receive the highest quality and most appropriate treatment for their cancer. SITC is continuing these quality efforts through stewardship and further development.

In 2022, CMS implemented SITC’s quality measure “Appropriate Intervention of Immune-Related Diarrhea and/or Colitis in Patients Treated with Immune Checkpoint Inhibitors” into the MIPS program. This measure aims to ensure any patient who experiences diarrhea and/or colitis while being treated with immune checkpoint inhibitors is cared for in a guideline-concordant manner. Building on the measure’s inclusion into MIPS, in 2023, the measure was added to the CMS Oncology Value Pathway (MVP), which helps to ensure its integration into day-to-day treatment impacting/improving patient quality of care.

This year, SITC’s second measure, “Positive PD-L1 Biomarker Expression Test Result Prior to First-Line Immune Checkpoint Inhibitor Therapy Measure,” is currently being considered for integration into the MIPS program. This measure aims to ensure that indication-concordant biomarker testing has occurred before receiving checkpoint inhibitors where appropriate. This quality measure is included on the 2023 “Measures Under Consideration” (MUC) list via CMS for potential inclusion into the 2024 MIPS program. SITC will continue to work through measure review into 2024.