Immuno-oncology therapeutics is leading to a transformational shift in treatment paradigms for patients with cancer. Development of novel drugs, biologics, and devices will likely lead to more effective therapies tailored to the unique immune biology within each cancer patient to stimulate, and orchestrate the body’s natural defenses as a treatment for their cancer while minimizing toxicities.
The Immuno-Oncology Therapeutics Program (IOTP) in the FDA Oncology Center of Excellence (OCE) will bring together existing expertise across the Centers within FDA and serve to promote development of new therapeutics that focus on harnessing the immune system to engage new, more efficacious treatment paradigms for patients with cancer. The IOTP will foster:

• Internal and External Education Programs
  • Education programs within the FDA to serve the training needs of staff to develop and to maintain expertise in the rapidly evolving field of immuno-oncology.
  • Communication programs with stakeholders of immuno-oncology therapeutics, including already approved products and novel products in development, to engage this community on the role of the OCE in furthering the development of immuno-oncology therapeutics.
• Regulatory Science Research to advance the development of immuno-oncology drugs, biologics, and devices in a manner that is guided by the unique features of these therapies that work directly with the biology of the immune system to deliver an effective cancer treatment.
• Novel Clinical Trial Paradigm advancement to efficiently evaluate the safety and effectiveness of immuno-oncology therapeutics, including combination regimens, as unique treatments that promise broad activity across cancer types.