Cancer Research Institute’s (CRI) annual Cancer Immunotherapy Insights & Impact report tracks 13 new FDA approvals and the structural shifts reshaping oncology drug development
NEW YORK, June 1, 2026 — Cancer immunotherapy is entering a new chapter, with 13 new FDA approvals in 2025, a first-ever treatment for a long-overlooked cancer, a shift in how foreign-developed drugs are reaching American patients, and the FDA opening faster paths to approval. Those are the central findings of the latest Cancer Research Institute’s Cancer Immunotherapy Insights & Impact (CI3) report, the most comprehensive, publicly available account of FDA immunotherapy approvals that provides a year-over-year view of how the field is evolving.
The latest report documents 13 new FDA cancer immunotherapy approvals in 2025, bringing the 14-year total to 156. But the more consequential developments emerged at the margins: the first-ever immunotherapy approval for anal cancer, a long-overlooked disease; FDA approval of a Chinese-developed drug, a structural shift in the global geography of innovation; and six drugs previously granted accelerated approval converted to regular approval status, reflecting a maturing regulatory environment that is holding drug approvals to a higher evidentiary standard.
“Immunotherapy has gone from a niche approach to a cornerstone of cancer treatment in just over a decade,” said Samik Upadhaya, PhD, Director of Scientific Affairs at CRI. “Thirteen new approvals in a single year are remarkable – but what’s more remarkable is the structural shifts we’re seeing in where oncology innovation is coming from, how the regulatory pathway is evolving, and which patient populations are now within reach of immunotherapy for the first time.”
When the FDA approved the first checkpoint inhibitor in 2011, a treatment that unleashes the body’s own immune system against cancer, immunotherapy became a major pillar of cancer treatment in the United States.
Key Findings from the 2025 Report
A first for anal cancer. Approximately 11,000 Americans are diagnosed with anal cancer each year, but no immunotherapy was approved for the disease until 2025. The approval of retifanlimab, in combination with chemotherapy, is a meaningful clinical advance that expands treatment options for patients with limited alternatives.
A structural shift in where cancer drugs come from. The approval of penpulimab, a checkpoint inhibitor developed by Chinese company Akeso, Inc., marks one of the first times a novel cancer immunotherapy developed entirely in China has reached the U.S. market without first being licensed to a Western pharmaceutical company. Historically, Chinese-developed oncology drugs entered the U.S. through partnerships with companies like Merck or AstraZeneca, which handled the clinical and regulatory work. Penpulimab’s independent approval signals that Chinese biotech companies are increasingly capable of meeting FDA standards on their own, marking a shift in the global oncology innovation landscape.
Faster regulatory approval. Six drugs previously granted accelerated approvals were converted to full approval status in 2025, the largest single-year cohort of such conversions on record in immunotherapy. Accelerated approvals let promising drugs reach patients faster, but require companies to run follow-up trials proving the drugs actually work as expected. A 2022 law gave the FDA stronger tools to hold companies to those follow-up commitments, and 2025’s wave of conversions suggests sponsors are now moving more quickly to complete that work. Additionally, dostarlimab received a Commissioner’s National Priority Voucher designation, signaling the FDA may be opening pathways for faster approvals in select cases.
Less time in the infusion chair. A subcutaneous version of pembrolizumab, Merck’s blockbuster Keytruda, was approved this year, following similar advances for other major checkpoint drugs. The shift from lengthy IV infusions to quick injections reduces the treatment burden for patients, but it could also make the drug harder to afford by extending how long it stays on the market without lower-cost competition.
The CI3 report has become the go-to resource for tracking the latest updates in the field, and it draws on CRI’s position as the world’s leading nonprofit funder of cancer immunotherapy research and its decades-long investment in advancing the science. This year’s CI3 report coincides with the release of CRI’s interactive data dashboard – making the full approval dataset publicly explorable for the first time, with accessibility and patient context built in from the ground up.
“Immunotherapy has transformed cancer treatment options for millions, but it still benefits only a fraction of patients and works only in a subset of cancer types,” said Upadhaya. “More research is needed to realize the full promise of this revolutionary field, and that progress is dependent on sustained public investment. While we celebrate the advancements made over this last year, we know that the work we’re doing in 2026 is critical not just to today’s cancer patients, but to patients who will benefit from this science in 5, 10, and 20 years.”
About the Cancer Research Institute
The Cancer Research Institute (CRI) is the world’s leading nonprofit organization dedicated exclusively to transforming cancer patient care by advancing scientific efforts to develop new and effective immunotherapies for all cancers. Founded in 1953, CRI has invested over $570 million in support of research conducted by immunologists and tumor immunologists at the world’s leading medical centers and universities, and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment.
