Five years after the formation of the FDA’s Oncology Center of Excellence (OCE), the federal center slowed the launch of new projects to focus on existing programs, with particular focus on ramping up four programs to help modernize clinical cancer trials.
Launched in 2017 and led by Director Richard Pazdur, M.D., the OCE is designed to expedite review of medical products for cancer treatment. In 2022, the center focused resources on improving the development of clinical trial data that respond to the modern needs of patients and physicians, Pazdur wrote in a message alongside the OCE’s 2022 Annual Report. Over the year, the OCE strengthened existing projects, guided by the theme of “modernizing evidence generation.”
The OCE listed four programs that either just launched or gained renewed focus in 2022. The newly launched Project Pragmatica aims to streamline clinical trials for approved oncology medical products via innovative trial designs. Project members work with patients, trial investigators, pharmas, government agencies and global healthcare policy stakeholders to assess opportunities and challenges tied to the pragmatic elements of running multiregional cancer trials like recruiting diverse populations, reducing time and cost associated with trials and speeding up recruitment.
The OCE also ramped up a program called Program Beyond Breakthrough, which is currently developing an internal pilot program focused on early interactions with companies that support dosage strategy selection for previously unapproved oncology products with an FDA breakthrough-designation tag.
Next on the roster is Project FrontRunner, which was launched in 2022 to push oncology drug development to earlier stages of the disease instead of testing new therapies for recurring or relapsed disease. In its inaugural year, program members met with stakeholders to assess interest and develop a framework for identifying clinical settings where the approach may be feasible.
Lastly, the OCE doubled down on Project Site Selector, an initiative born from the increasing number of registration applications for oncology trials that had either no or very few participants from the U.S. In July 2022, Project Site Selector held its inaugural public panel discussion and has another related series of workshops and panel discussions slated for this year.
Project Equity, though not listed as one of the programs that received extra attention last year, certainly had a noteworthy 2022. Project Equity was the lead author of the FDA draft guidance—titled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials”—that was released in April and expounded upon the agency’s 2021 guidance to increase clinical trial diversity.
The draft guidance encourages drugmakers to create and submit racial and ethnic recruitment plans for clinical trials early in the drug development process to boost participation in underrepresented populations. The guidance comes after several advocacy groups urged more diversity efforts, though recent studies and surveys show there’s a lot more work to be done.
Of course, the OCE also helped approve several new drugs and products in 2022. The center collaborated with the Office of Oncologic Diseases in the Center for Drug Evaluation and Research to approve 11 new drugs or biologic agents for treating multiple cancer types, along with 29 labeling expansions.
The OCE and the Center for Biologics Evaluation and Research also approved two new cell therapies—Johnson & Johnson and Legend's Carvykti for multiple myeloma after four previous therapies and Ferring’s adstiladrin, the first approved gene therapy for bladder cancer. The OCE also worked with the Center for Devices and Radiological Health to authorize 54 oncology-related devices in 2022.