A half-decade after launching its Oncology Center of Excellence (OCE), the FDA is signaling an overall slowdown of new project green lights in the interest of bolstering existing programs and bringing modernized methodology to its clinical trials. Specifically, four extant or entirely new programs will be ramped up with this renewed focus to help with much-needed modernization.
It’s not the first time the fairly young organization has had the word “modern” plastered all over its press releases. Last year, as led by Director Richard Pazdur, M.D., the OCE honed in on improving clinical trial data development to better fit the modern needs of physicians and patients alike, with the general theme of, as Pazdur put it, “modernizing evidence generation.” Projects FronterRunner, Site Selector, and Beyond Breakthrough are in-place programs that will receive extra attention, with Project Pragmatica being the new kid on the block. That project looks to accelerate clinical trials for certified oncology products with fresh-minded trail designs.
The OCE is simultaneously responsible for several new drug and product approvals in 2022. Eleven new drugs or biological agents for cancer treatment and 29 labeling expansions were enabled via collaboration with the Office of Oncologic Diseases in the Center for Drug Evaluation. Also among its partnerships were the Center for Biologics Evaluation and Research
as well as the Center for Devices and Radiological Health. The former team-up saw the approval of two new cell therapies and the latter pairing authorized 54 oncology-related devices.