New York, NY — The Cancer Research Institute (CRI), a nonprofit organization dedicated to advancing immune-based treatments for cancer, has released its inaugural 2025 Cancer Immunotherapy Insights and Impact report—an authoritative, data-driven review of the evolution of cancer immunotherapy over the past decade along with an in-depth look at key developments from the past year.
The report synthesizes more than 150 U.S. Food and Drug Administration (FDA) approvals from 2011 through 2024, offering a comprehensive view of how immunotherapy has evolved from a scientific breakthrough to standard of care across dozens of cancer types.
In 2024 alone, the FDA approved 17 new immunotherapy agents, including several historic firsts:
- The first-ever tumor-infiltrating lymphocyte (TIL) therapy for solid tumors
- The first TCR-engineered therapy for a solid tumor indication
- A first-in-class IL-15 agonist to treat bladder cancer
- And newly approved subcutaneous checkpoint inhibitors that expand access and reduce infusion burden for patients
“The story of cancer immunotherapy is still being written—and its next chapter promises to be its most transformative yet,” said Dr. Alicia Zhou, CEO of CRI. “With this report, we aim to provide a clear, evidence-based picture of the field’s momentum and to spotlight the science and strategies that are being employed today.”
Key highlights of the report include:
- A decade-long analysis of immunotherapy approvals by cancer type, therapeutic class, and delivery method
- An in-depth review of 2024’s historic FDA approvals, including real-world impact and trial outcomes
- Insights into next-generation trends, such as targeted vaccines, neoadjuvant immunotherapy strategies, and combination and bispecific antibody therapies
- A visual summary of the diversity and breadth of immunotherapy drugs now in use and in development
The 2025 CRI Insights + Impact report is released during Cancer Immunotherapy Month (June), as part of CRI’s broader mission to educate, engage, and empower patients, researchers, and advocates alike.
