FDA's 2025 Report on Progress in Cancer Treatment and Care

Dear Cancer Community Members,  

 

We're pleased to share the FDA Oncology Center of Excellence's (OCE) 2025 Annual Report, which outlines our efforts to achieve patient-centered regulatory decision-making through innovation and collaboration.  Some of last year’s important milestones for patients and caregivers included:  

  • Approvals of 17 new cancer treatments  
  • Approvals of 12 different drugs and biologics for pediatric patients with cancer 
  • Collaboration with regulatory agencies in other countries to speed up access to new treatments 
  • Continuation of OCE’s Rare Cancers Program to gather real-world experiences from patients 
  • Assistance with 675 patients seeking access to experimental treatments through the FDA’s Expanded Access program 

The report also features a Director’s Message from Dr. Angelo De Claro, who became OCE Director in May 2026 

 

To learn more about how we're working to improve cancer care, please read our full report: https://www.fda.gov/about-fda/oce-annual-reports/2025-oce-annual-report

 

Your voice matters in our work. We encourage you to stay informed and involved in the fight against cancer. 


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