The FDA approved 13 new immunotherapies in 2025, down from 22 approvals in 2024, according to the Cancer Research Institute “Cancer Immunotherapy Insights & Impact” report published June 1.
The Cancer Research Institute tracks and analyzes FDA cancer immunotherapy approvals from 2011 through 2025 for the report.
Here are five things to know:
- Over the past 14 years, the FDA has approved 156 cancer immunotherapies.
- Eleven of the 13 immunotherapies approved by the FDA in 2025 were immune checkpoint inhibitors, which have also accounted for 77% of FDA immunotherapy approvals since 2011.
The remaining two immunotherapies approved in 2025 were a bispecific antibody and a cell and gene therapy. - The 13 immunotherapy approvals in 2025 were for:
- Bladder cancer: 2
- Colorectal and anal cancer: 2
- Esophageal cancer: 1
- Gastric cancer: 1
- Head and neck cancer: 2
- Hematological cancer: 2
- Lung cancer: 1
- Skin cancer: 1
- Multiple cancer types: 1
- Penpulimab — a PD-1 immune checkpoint inhibitor from Akeso Biopharma — became the first Chinese immunotherapy agent to receive FDA approval.
- The FDA approved the first immunotherapy for anal cancer in 2025, retifanlimab.
Read the full report here.
