Policy & Advocacy

FDA Engagement

SITC leadership continues to emphasize the importance of our engagement/collaboration 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. Building on the initial successes from 2023, SITC continues to provide comment on recently released FDA guidance relevant to the IO community. This process allows for SITC to significantly impact the regulatory landscape for current and future immunotherapies. When the FDA releases new guidance documents, SITC committees assess the impact of the document and whether the scope of the work falls within SITC’s purview. If so, SITC committee members and staff work to generate comments on the proposed guidance and submit proposed revisions/questions on behalf of the society. To date, SITC has or is considering to submit comment on the following draft FDA guidance documents in 2024:

•    Potency Assurance for Cellular and Gene Therapy Products
•    Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
•    Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
•    Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products

Advocating for Increased Funding for Immunotherapy Research

Continued support for federal funding of cancer immunotherapy research is a cornerstone of SITC's policy initiatives. As an individual organization and a member of research coalitions like One Voice Against Cancer, SITC employs numerous strategies to advance this goal. A key annual activity is drafting appropriations language, where SITC members develop and advocate for immunotherapy-focused text to be included in federal appropriations bills. These bills guide funding priorities for the National Cancer Institute (NCI) and the Food and Drug Administration (FDA).

Each piece of appropriations language addresses a member-identified challenge within the immunotherapy field. When included, this language becomes a federally mandated focus area, requiring the NCI and FDA to justify funding for these priorities in the following year. Since 2017, SITC’s language has been successfully incorporated into every federal appropriations bill.

This year, the Policy, Science and Research Subcommittee, along with the Regulatory Subcommittee, crafted a cohesive message emphasizing the timing and sequencing of cancer immunotherapy. The NCI language prioritized research support for moving immunotherapy into earlier lines of treatment, while the FDA language focused on regulatory validation of surrogate endpoints for early-stage clinical trials.

SITC staff and volunteers played a critical role in advocating for this language, meeting with lawmakers both in person and virtually. During this year’s Hill visits, nine SITC volunteers engaged with over 30 congressional offices, fostering relationships with representatives and senators while educating Congress on the importance of immunotherapy and SITC’s contributions to the field.

To date, SITC’s appropriations language has been included in the draft FY2025 appropriations bills, with final congressional approval still pending. These efforts not only advance federal support for immunotherapy research but also provide valuable opportunities for SITC volunteers to actively participate in shaping the future of cancer treatment.

Comment Letters

Comment letters are an effective tool for SITC to provide direct feedback and recommendations to policymakers on issues impacting the field of immunotherapy. Whether working independently or collaborating with other organizations, these letters are a vital component of SITC’s advocacy efforts throughout the year. Drafted by the SITC Policy Committee and other relevant committees, each letter is reviewed and approved by the Executive Committee and/or Board of Directors to ensure alignment with organizational priorities.

This year, SITC has signed or authored seven letters addressing a range of topics, including Centers for Medicare & Medicaid Services (CMS) rulemaking, requests for information, and funding priorities:

• Accelerating Kids Access to Care Act: Signed a letter with the Leukemia & Lymphoma Society and over 230 organizations advocating for the inclusion of this act in FY25 funding bills. The act aims to ensure coverage for pediatric patients requiring advanced care across state lines
• 21st Century Cures Initiative: Submitted a letter in response to a congressional request for information, emphasizing the need for future regulatory guidance and enhanced cross-agency collaboration to advance the field
• CMS Inpatient Prospective Payment System: Provided detailed comments on the CMS FY25 proposed changes, addressing the potential impacts on reimbursement for immunotherapies
• Rare Disease Research: Responded to a congressional request for information on biomedical research for rare diseases, highlighting immunotherapy’s contributions to this area and the role of Congress in supporting these advancements
• Cancer System Immunology: Submitted comments to the NCI emphasizing the potential of advanced bioinformatics and machine learning in immunotherapy research
• Control Arm Crossover in Clinical Trials: Sent a letter to the Oncologic Drug Advisory Committee addressing the use of control arm crossover in immunotherapy clinical trials, advocating for thoughtful consideration of its impact
• Research Funding Advocacy: Signed a letter with the One Voice Against Cancer Coalition urging robust FY24 funding levels for the National Institute of Health (NIH), NCI, and Centers for Disease Control (CDC)

Release Criteria

SITC published a meeting report summarizing the outcomes of the SITC Release Criteria Summit. This summit brought together a diverse group of cellular therapy experts, including representatives from major academic centers, industry, and regulatory agencies, to provide recommendations on the application, utility, and role of release criteria within the regulatory process.

The summit was organized into three panels, each addressing a critical aspect of release criteria:

• Current Commercial Products: Examined existing release criteria and their practical application
• Potency as a Release Criterion: Explored the challenges and opportunities of using potency as a regulatory metric
• Future Development of Ideal Release Criteria: Focused on envisioning and defining the characteristics of optimal release criteria for the field

Each panel identified key challenges within their respective topics and proposed actionable solutions to address these hurdles. As a follow-up to the summit and the subsequent report, the SITC Cellular Therapy Committee is now developing a collaborative manuscript. This document will delve deeper into the concept of phase-dependent approaches to potency and release criteria for cellular therapies, providing a more comprehensive framework for the field. The full meeting report is available at this link.

SITC Quality Measures Project

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:

• The SITC measure on PD-L1 biomarker testing was newly implemented this year into the CMS Merit-based Incentive Payment System (MIPS) Quality Payment Program and the Oncology Measure Value Pathway
• Both measures are now part of CMS programs, allowing providers to receive reimbursement for delivering high-quality care to immunotherapy patients

Current SITC Quality Measures:

• 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