Director’s message:

The FDA Oncology Center of Excellence, authorized by the 21st Century Cures Act, was established in January 2017 to help facilitate the development and clinical review of anti-cancer therapies by uniting scientific experts across the Agency’s product centers to conduct expedited review of drugs, biologics, and devices.

In the two years since its formation, the OCE has collaborated with FDA’s medical product centers to expedite many important clinical reviews, including the first two chimeric antigen receptor T-cell therapies for the treatment of advanced hematologic malignancies, and the first approvals of site-agnostic indications. The OCE also created two pilot programs to improve the process of evaluating data and evidence to generate a benefit-risk assessment which informs regulatory decisions: the Real-Time Oncology Review and the Assessment Aid. Our experts have led the development of 12 guidance documents on important aspects of oncology and malignant hematology product development.

In 2018, we established a core OCE management team and continued the work begun in 2017 of building programs and launching initiatives to leverage expertise across the FDA and other Federal health agencies, as well as academia, community practitioners, and industry, to advance the development and regulation of products for people with cancer.

To be effective, we must collaborate with our stakeholders to develop discussions that will have an impact on product regulation. In the past two years, we held more than 60 symposiums bringing academics and key therapeutic leaders to the FDA. We also held two workshops for patient advocates to discuss the important role they can play in oncology product development. Often these conferences were conducted jointly with oncology professional societies, patient groups, and leading cancer centers. By emphasizing external outreach and the academic development of our staff, the OCE can create a dynamic regulatory environment responsive to rapidly emerging scientific advances.

Richard Pazdur, MD
Director, Oncology Center of Excellence

[Published March 2019]